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{ "NCT_ID" : "NCT02308631", "Brief_Title" : "Endoscopically Assisted Colostomy With Colopexy for Critically Ill Patients Without General Anesthesia or Laparotomy", "Official_title" : "ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY", "Conditions" : ["Colonic Neoplasms", "Rectal Neoplasms", "Fecal Incontinence"], "Interventions" : ["Procedure: ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Indications for colostomy are rectal or anal cancer, diverticular disease, radiation enteritis, complex perirectal fistulas, anorectal trauma, severe incontinence, motility and functional disorders. It is frequently required in critically ill patients who may not be able to tolerate a laparotomy. Laparoscopic-assisted colostomy is an alternative method for colostomy without laparotomy, but require general anesthesia. Additionally, percutaneous anterior colopexy under colonocopic control offers the possibility for improved and faster fixation of the anterior colonic wall to the anterior abdominal wall. The objective of this study is to evaluate the feasibility of performing fecal diversion with the help of a colonoscope and colopexy, without the additional morbidity of abdominal exploration. Detailed Description The colonoscope will be passed transanally into the left colon. It will be identified the endoscopic transilluminating point to the abdominal wall. Percutaneous anterior colopexy will be performed, using a gastropexy device that is included in the percutaneous endoscopic gastrostomy (PEG) kit . This technique involves the placement of a threaded nylon fastener into the colon through a needle. The endoscope will be manipulated until the light approaches the premarked site. A small skin disc will then be removed at this location and a loop colostomy will be made. The colonoscope will also be used as a guide to identify the proximal and distal limbs of the loop colostomy. #Intervention - PROCEDURE : ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY - The endoscope was manipulated until the light approached the pre-set for the use of transillumination site and puncture with the Loop Fixture II gastropexy kit

#Eligibility Criteria: Inclusion Criteria: * good health and without surgery Exclusion Criteria: * Sex : FEMALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT02308631

{ "NCT_ID" : "NCT00477542", "Brief_Title" : "A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT", "Official_title" : "A Phase I Trial of Myeloablative Conditioning Using Clofarabine and High-Dose Busulfan for Patients With Refractory Hematological Malignancies Undergoing Allogeneic HSCT", "Conditions" : ["Hematologic Malignancies"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with a myeloablative dose of busulfan. This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease Detailed Description All patients will receive the same dose of busulfan. The dose of clofarabine will be escalated in successive cohorts of patients. Using a standard dose escalation design, successive cohorts of 3 patients will be treated with escalating doses of clofarabine. At the MTD (or highest dose-level if the MTD is not reached), the cohort will be expanded to 10 patients to better investigate correlative studies and give some preliminary idea of efficacy. #Intervention - DRUG : clofarabine - Cohort- n- Clofarabine (mg/m2/day) -1 3-10 20 1. 3-6 30 2. 3-6 40 3. 3-6 50 4. 3-6 60 5. 6-10 70

#Eligibility Criteria: Inclusion Criteria: * Documentation of disease. Patients must have one of the following disease types: * Acute myeloid leukemia (AML) with either: * Primary refractory to induction chemotherapy * Relapsed and refractory AML with >5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system). * Patients in second or subsequent complete remission (CR2, CR3, etc.). * Acute lymphoblastic leukemia (ALL) with one of the following criteria: * Primary refractory to induction chemotherapy. * Relapsed and refractory ALL with >5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system). * Patients in second or subsequent complete remission (CR2, CR3, etc.). * Myelodysplasia, refractory anemia with excess blasts with 11 <= age <= 20% blasts in the bone marrow (RAEB II). * Chronic myelogenous leukemia (CML) with one of the following criteria: * Accelerated phase. * Patients in blast crisis. * Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the following criteria: * Failure to achieve complete remission to primary induction therapy * Relapsed NHL, refractory to at least one line of salvage systemic therapy * Patients who relapse < 6 months following autologous stem cell transplantation are not eligible. * Patient age 18 <= age <= 60 years * Availability of a consenting HLA-matched donor * Performance status ECOG 0 <= age <= 1 * No active infection. Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection. * No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies. * Non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. Women of childbearing potential should have a negative pregnancy test prior to study entry. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom). * Required baseline laboratory values: * LVEF > 45% corrected * DLCO > 50% of predicted value (corrected for hemoglobin) * Serum creatinine <= 2.0 mg/dl or estimated creatinine clearance of >=60 ml/min * Bilirubin < 1 x upper limit of normal value * AST and ALT < 1 x upper limit of normal value * Signed written informed consent. Patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. Exclusion Criteria: * Patients who relapse < 6 months following autologous stem cell transplantation are not eligible Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT00477542

{ "NCT_ID" : "NCT00003875", "Brief_Title" : "Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia", "Official_title" : "Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 (IL-2) Immunotherapy", "Conditions" : ["Adult Acute Myeloid Leukemia in Remission", "Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities", "Adult Acute Myeloid Leukemia With Del(5q)", "Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)", "Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)", "Childhood Acute Myeloid Leukemia in Remission", "Recurrent Adult Acute Myeloid Leukemia", "Recurrent Childhood Acute Myeloid Leukemia"], "Interventions" : ["Procedure: peripheral blood stem cell transplantation", "Drug: busulfan", "Drug: etoposide", "Biological: aldesleukin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial studies the side effects and how well giving busulfan and etoposide followed by peripheral blood stem cell transplant (PBSCT) and low-dose aldesleukin works in treating patients with acute myeloid leukemia (AML). Drugs used in chemotherapy, such as busulfan and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A PBSCT may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more cancer cells are killed. Aldesleukin may stimulate the white blood cells to kill cancer cells. Giving busulfan and etoposide together followed by PBSCT and aldesleukin may be an effective treatment for AML. Detailed Description PRIMARY OBJECTIVES: I. To evaluate the toxicity and overall survival of high dose Bu (busulfan)/VP-16 (etoposide) followed by post-transplant low-dose interleukin (IL)-2 (aldesleukin) in patients with AML. SECONDARY OBJECTIVES: I. To estimate the rate of relapse associated with this regimen. OUTLINE: PREPARATIVE REGIMEN: Patients receive busulfan intravenously (IV) over 2 hours or orally (PO) every 6 hours on days -7 to -4 and etoposide IV on day -3. STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0. POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients receive low-dose aldesleukin subcutaneously (SC) daily for 12 weeks. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. #Intervention - DRUG : busulfan - Given PO or IV - Other Names : - BSF, BU, Misulfan, Mitosan, Myeloleukon - DRUG : etoposide - Given IV - Other Names : - EPEG, VP-16, VP-16-213 - BIOLOGICAL : aldesleukin - Given SC - Other Names : - IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2 - PROCEDURE : peripheral blood stem cell transplantation - Undergo autologous or syngeneic stem cell rescue - Other Names : - PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

#Eligibility Criteria: Inclusion Criteria: * The patient must have AML that falls into one of the following categories: * AML in 1st complete remission (CR) with intermediate or high risk of relapse following conventional therapy; at least, one of the following features is needed: * Patient required more than one cycle of induction to achieve first CR * White blood cell count (WBC) > 100,000/mm^3 at diagnosis * Any of the following cytogenetic abnormalities: inv (3), t(3:3), del (5q) or -5, 11q23, del(7q) or -7, del (20q) or -20, abnormal 12p, +11 or t8 * Any other abnormalities or combination of abnormalities which would predict intermediate or high risk of relapse * AML beyond first CR * Any patient with an identical twin donor who also meets the criteria above * Patients with AML in 1st CR should receive at least two cycles of consolidation chemotherapy prior to mobilization and transplant * Patients must have an adequate number of stem cells previously collected (i.e., > 2 x 10^8 total nucleated cell [TNC] of bone marrow [BM]/kg or 4 x 10^6 [CD]34+ PBSC/kg, unless approved otherwise by Dr. Holmberg); prior to stem cell collection patients must be documented to be in remission and to have received two cycles of consolidation therapy after induction therapy * Pre-Study tests have been performed * Patient must sign an institutional review board (IRB) approved informed consent, conforming with federal and institutional guidelines Exclusion Criteria: * Patients with good risk AML defined by cytogenetic evaluation with these abnormalities: inversion 16 or t8;21 * Patient's life expectancy is severely limited by diseases other than AML * Patient is human immunodeficiency virus (HIV) seropositive * Patient is pregnant * Patient's creatinine > 2.0 mg/dl * Patient's total bilirubin > 2.0 mg/dl (unless Gilbert's disease) * Or serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) >= 2.5 x upper limit of normal (ULN) not due to leukemia * Patient has a history of congestive heart failure, uncontrolled arrhythmias or left ventricular ejection fraction (LVEF) < 50% * Patient has an unrelated human leukocyte antigen (HLA) matched donor and is eligible for a higher priority Fred Hutchinson Cancer Research Center (FHCRC) protocol (for FHCRC patients only) * Patient has an HLA matched or one antigen mismatch family donor available * Patients with a significant active infection that precludes transplant * Patients with a Karnofsky Performance Score less than 70 Sex : ALL Ages : - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00003875

{ "NCT_ID" : "NCT00387322", "Brief_Title" : "Pemetrexed Disodium and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors", "Official_title" : "Phase I/II Study of Two Different Schedules of Pemetrexed (ALIMTA) and Erlotinib (TARCEVA) in Advanced Solid Tumors, With Emphasis on Non-Small Cell Lung Cancer (NSCLC)", "Conditions" : ["Lung Cancer", "Unspecified Adult Solid Tumor, Protocol Specific"], "Interventions" : ["Drug: erlotinib hydrochloride", "Drug: pemetrexed disodium"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary RATIONALE: Pemetrexed disodium and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pemetrexed disodium together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of pemetrexed disodium and erlotinib and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors. Detailed Description OBJECTIVES: Primary * Determine the safety and feasibility of combining pemetrexed disodium with erlotinib hydrochloride in patients with advanced non-small lung cancer (NSCLC) or other solid tumors. (Phase I) * Determine the response rate in patients with NSCLC treated with pemetrexed disodium in combination with erlotinib hydrochloride. (Phase II) Secondary * Compare toxicity differences between different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I) * Determine the maximum tolerated dose (MTD) of 2 different schedules of pemetrexed disodium and erlotinib hydrochloride. (Phase I) * Determine, preliminarily, the efficacy of the combination of pemetrexed disodium and erlotinib hydrochloride in patients with advanced solid tumors. (Phase I) * Assess the overall survival and progression-free survival. (Phase II) * Determine the frequency and severity of toxicities associated with the administration of pemetrexed disodium and erlotinib hydrochloride. (Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II open-label study. * Phase I: Patients are assigned to 1 of 2 treatment groups in an alternating fashion. Once accrual to the first dose level in group 1 is complete, group 2 will open for accrual to its first dose level. * Group 1: Patients receive oral erlotinib hydrochloride once on days 2, 9, and 16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression. * Group 2: Patients receive oral erlotinib hydrochloride once daily on days 2-16 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of unacceptable toxicity or disease progression. In both groups, patients may continue to receive erlotinib hydrochloride alone after completion of 6 courses of erlotinib hydrochloride in combination with pemetrexed disodium. In both groups, cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and pemetrexed disodium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive pemetrexed disodium at the MTD and erlotinib hydrochloride at the MTD as in group 1 or 2 (whichever is more favorable). After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study. #Intervention - DRUG : erlotinib hydrochloride - Given orally - Other Names : - Tarceva - DRUG : pemetrexed disodium - Given IV - Other Names : - Alimta

#Eligibility Criteria: Inclusion Criteria: * For the phase I portion of the study patients must have cytologically or histologically proven advanced solid tumors for which there is no standard effective therapy available. For the phase II portion patients must have cytologically or histologically proven selected stage IIIB (pleural effusion) or IV NSCLC. Patients with NSCLC that have progressed or recurred after first-line therapy for stage IIIA or IIIB may also be considered. * For the phase II portion patients must have disease that has progressed or recurred after treatment with platinum-based therapy. * Any number of prior chemotherapy regimens are allowed for the phase I portion and no more than 1 previous treatment for advanced NSCLC is allowed for the phase II portion. * Patients must have measurable disease by RECIST criteria. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. Patients with evaluable disease (bone metastases, pleural fluid, ascites, etc.) may be included in the phase I portion of the trial. * Patients must be 18 years or older. * Patients must have a performance status of 0 <= age <= 2 for phase I portion of study and a performance status of 0 -1 for the phase II portion of the trial. * Patients must have an estimated survival of at least 3 months. * Any prior chemotherapy that patients have received has to have been completed at least 4 weeks prior to start of treatment. For prior mitomycin chemotherapy a 6-week interval is required. Prior radiation must have been completed at least 2 weeks prior to start of therapy. Patients must have recovered from acute reversible side effects of prior chemotherapy regimens or radiotherapy to NCI-CTC < grade 1 (excluding alopecia). * Patients must have adequate renal function as documented by a serum creatinine < 1.5 mg/dl or a calculated creatinine clearance of > 45 ml/min (see appendix for formula for calculating creatinine clearance). * Patients must have adequate liver function as documented by serum bilirubin < 1.5 x ULN. AST must be < 2.5 x institutional upper limit of normal. * Patients must have a pretreatment granulocyte count of >1500/mm3 and platelet count of >100 000/mm3. * Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks. Because of the possibility of treatment related neurological toxicity it is difficult to evaluate for toxicity in the presence of symptomatic brain metastasis. * All patients must give voluntary written informed consent. * Patients must be able to take and retain oral medication. * Patients of reproductive potential must agree to use effective contraceptive method while on treatment and for 3 months afterwards as the effects of these drugs on the unborn fetus are unknown. * Patients on coumadin should have their INR monitored at least once per week or more frequently depending on the investigators judgement. There have been some case reports of increased INR when coumadin is co-administered with OSI-774/placebo. Exclusion Criteria: * Patients may not have previously received Pemetrexed or an EGFR-directed therapy. * Females can not be pregnant or breastfeeding as the effects of these drugs on the unborn fetus are unknown. Documentation of a negative serum pregnancy test is required for all women of reproductive potential. * Patients with symptomatic brain metastasis or still requiring steroids and anti-convulsants may not be included. * No other prior malignancy is allowed for the phase II portion except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for over five years. * Patients cannot take non-steroidal anti-inflammatory agents (NSAIDS) or salicylates 2 days prior and 2 days following (5 days pre and post for long-acting NSAIDS) administration of pemetrexed due to concerns of increased risk of renal toxicity. * Patients with clinically significant ophthalmologic abnormalities will be excluded. This includes severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren's syndrome, severe exposure keratopathy, or other disorders that might increase the risk of corneal epithelial injury. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00387322

{ "NCT_ID" : "NCT04795128", "Brief_Title" : "A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy", "Official_title" : "A Phase I Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy", "Conditions" : ["Hematologic Malignancy"], "Interventions" : ["Biological: IBI322"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment. Detailed Description This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies. #Intervention - BIOLOGICAL : IBI322 - Recombinant anti-human CD47/PD-L1 bispecific antibody injection

#Eligibility Criteria: Inclusion Criteria: * Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment * At least one evaluable lesion * Male or female 18 <= age <= 75 old * Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0 <= age <= 2 * Must have adequate organ function Exclusion Criteria: * Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein * Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T) * Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies * Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start * A history of blood transfusion within 2 weeks prior to study start Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04795128

{ "NCT_ID" : "NCT01085838", "Brief_Title" : "Erlotinib in Higher Risk Myelodysplastic Syndrome", "Official_title" : "Phase I-II Trial of Erlotinib in Higher Risk Myelodysplastic Syndrome", "Conditions" : ["Myelodysplastic Syndrome"], "Interventions" : ["Drug: Erlotinib"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent. Detailed Description This is a phase I-II multicenter, open label, sequential cohort dose escalation study of erlotinib designed to assess the safety and efficacy of a daily administration of erlotinib in high risk MDS patients. Five patients per cohort will be enrolled into sequential cohorts receiving increasing dosages of erlotinib. The first cohort of 5 patients will start with a dosage of 100 mg erlotinib daily. Response will be determined after 12 weeks of treatment (or earlier upon major hematologic improvement, whichever event occurs first). At the completion of each cohort, defined as the fifth subject completing the week 12 visit, the safety review panel will be responsible for making the decision as to whether the next cohort will begin, an intermediate dose cohort will be added, or if additional subjects will be enrolled into an earlier dose cohort. Upon agreement of the safety review panel, the second cohort of patients will receive 150 mg of erlotinib daily, and - upon agreement of the safety review panel - the third cohort of five patients will be enrolled to receive 300 mg of erlotinib daily. Since it is to be expected that the therapeutically required dosage of erlotinib is higher than the dosage for which a patient was initially enrolled (i.e. patient enrolled in the first cohort receiving 100 mg daily), dosage of erlotinib should be increased (for the same patient) to the next higher level, if no response is documented after 12 weeks of continuous treatment and no grade III or IV toxicity is documented. In contrast, responders will continue their treatment with the same dosage of erlotinib until grade III or IV toxicity arises or treatment loses efficacy (as defined by relapse/progression of the disease). Consequently, this study plans to enrol 15 patients in 3 cohorts of 5 patients. Once the dose limiting toxicity has been defined, additional confirmatory subjects (20) will be enrolled into the appropriate lower dose as recommended by the safety review panel. #Intervention - DRUG : Erlotinib - Erlotinib oral capsule, 100, 150, or 300 mg/day during 12 weeks at study start - Other Names : - OSI-774

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of MDS according to the WHO classification, but also including RAEB in transformation as defined by the FAB classification (that is patients with up to 30% of blasts in the bone marrow), with the exception of patients with preceding myeloproliferative syndrome or LMMC; * Higher-risk MDS as defined by a IPSS score >1 (IPSS: Int-2 or High); * Life expectancy > 3 months; * Percentage of bone marrow blasts >10 and below 30%; * Ineligible for or having failed intensive chemotherapy and ineligible for or having failed previous therapy with a hypomethylating agent; * Age >= 18 years; * Written informed consent; * Patient must understand and voluntarily sign consent form; * Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements; * ECOG performance status between 0 <= age <= 2 at the time of screening; * Females of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who is not naturally postmenopausal for at least 24 consecutive months, that is who has had menses at any time during the preceding 24 consecutive months) have to have a negative pregnancy test; * Adequate contraceptive methods should be carried out by all patients during therapy and for at least 2 weeks after completing therapy. * No existing contra-indication to treatment with erlotinib. * Health insurance. Exclusion Criteria: * Serum creatinine >= 1.5 x the upper limit of normal, or creatinine clearance <=60 mL/min. * Concomitant treatment with NSAIDS, warfarin, omeprazole, ranitidine or inducers (i.e. rifampicin, phenytoin; carbamazepin) or inhibitors (i.e. ketoconazole, ciprofloxacin, clarithromycin, voriconazole) of CYP3A4; * Inadequate liver function as defined by a serum bilirubin >= 1.5 x the upper limit of normal (except in the case of confirmed moderate unconjugated hyperbilirubinemia due to intramedullary hemolysis, as observed frequently in MDS), and/or ASAT/ALAT/GGT levels >=2 x the upper limit of normal; * Known HIV-positivity; * Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study; * Vitamine B12 or folate deficiency; * Pregnant or lactating females; * Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within the 28 days preceding study entry; * Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast), unless the subject has been disease-free for >=3 years; * Patients with a history of corneal disorders or another active ophthalmic disorder, active infections or other concomitant serious and uncontrolled medical conditions. * History of interstitial lung disease or any active pulmonary disease. * Patients with a history of myeloproliferative syndrome or LMMC Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01085838

{ "NCT_ID" : "NCT00389883", "Brief_Title" : "Anaesthesia for Supratentorial Tumor Resection", "Official_title" : "Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil", "Conditions" : ["Supratentorial Neoplasms"], "Interventions" : ["Drug: Comparison of two anesthetics protocol"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This is a double center, multidisciplinary, prospective, randomized, double-blind, with a superiority hypothesis, trial including 100 patients scheduled for resection of a supratentorial brain tumour under general anesthesia. Detailed Description On the morning of surgery, patients will be randomly allocated to one of the two following groups : target concentration-delivered propofol-remifentanil versus sufentanil-sevoflurane. The primary judgement criterion will be the rapidity of awakening, defined as the time between the cessation of administration of the last anesthetic until extubation. Several secondary judgement criteria related to quality of postoperative recovery and complications will be collected. The hypothesis tested is a 30% reduction of the time necessary to extubate patients after cessation of anesthetic delivery in the propofol-remifentanil group. Based on previous works, using an risk of 20 % and an of 5 %, 100 patients must be included in this study (50 or each group). Statistical analysis will be performed by WILCOXON MANN, WHITNEY and X2 tests based on the type of variables. The results of this study should provide a first choice anaesthetic regimen to optimize postoperative recovery of neurosurgical patients undergoing resection of supratentorial brain tumours. They will contribute to the improvement in the management of patients suffering from cancer. #Intervention - DRUG : Comparison of two anesthetics protocol - Comparison of two anesthetics protocol

#Eligibility Criteria: Inclusion Criteria: * Patient scheduled for supratentorial brain tumors remove. * Age : 18 to 75. * ASA 1 or 2. Exclusion Criteria: * Disagree of patient to participate * Intubation required in the postoperative care unit * Contraindication of one of the anesthetics used in the study * Pregnancy * Craniotomy in the frontal area (no depth of anesthesia monitoring) * Patient's inability to quantified its pain. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00389883

{ "NCT_ID" : "NCT06607835", "Brief_Title" : "Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning", "Official_title" : "A Preliminary Study Looking at the Use of Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning Among Women Post Gynaecological Cancer Treatment", "Conditions" : ["Sexual Pain Disorders"], "Interventions" : ["Behavioral: Mindful- compassion", "Behavioral: Mindful-compassion and cannabis suppositories"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce vaginal pain during sexual intimacy among women post-gynaecological cancer treatment. Outcomes are also hoped to increase sexual functioning, well-being, sexual self-efficacy and quality of life. Research intention: If the combined mindful compassion and cannabis suppository intervention reduces vaginal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services. A brief overview of the intervention: Mindfulness has been anecdotally discussed in reducing symptoms of vaginal pain and increasing overall well-being. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Vaginal suppositories do not create a euphoric high in the same way as oral use, including inhalation. Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included eighty-three consenting participants. Of these, forty-one were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study. Detailed Description Research looking at mindfulness-based interventions or the use of medical cannabis to support sexual pain is limited, and often, sexual pain goes unreported, which might lead to compromised psychological well-being. Additionally, sexual problems associated with pain and related emotional suffering are frequently overlooked in patients with sexual pain, particularly among those who are post cancer treatments. This research aims to establish the effectiveness of an online mindful compassion intervention adjunct with cannabis suppositories to help minimise sexual pain and increase well-being. This research decided to deliver mindful compassion online because it would economically target a more comprehensive and diverse group. This preliminary study examined how a mindful compassion intervention combined with cannabis suppositories might help minimise sexual pain whilst improving sexual function, well-being, sexual self-efficacy and quality of life. The main exercises included mindfulness, breathing, relaxation techniques, Mindfulness of the senses and body, and understanding the self. These exercises incorporated the three-model system of emotions, how to attend to the cognitive and physical patterns associated with painful sex, and towards acceptance and self-compassion with fewer symptoms. The mindful-compassion intervention included psychosexual education and vaginal pain, the three-model system of emotions and sexual pain, practising mindful compassion and graded practice and self-care, efficacy, and the relationship with anatomy. Homework exercises, including education, training, modelling, and enablement, were encouraged. Feedback and support, along with discussing the educational components, training, modelling, and enablement, were addressed throughout this study. The development of mindful compassion intervention has been based on a taxonomy of behavioural change techniques. This has been used because the taxonomy of behavioural change techniques has been rigorously tested to evidence the effectiveness in supporting interventions associated with change behaviour. The 93 behaviour change techniques are the active ingredients of behaviour change, and each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. The intervention in this study included twelve domains, of which twenty-three out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a triangulation process to ensure consistency in mapping the behaviour change techniques to the intervention. Randomisation was based on whether participants were already using cannabis suppositories or not. Those who did use cannabis suppositories as part of their sex life would have been doing so for at least a month. There was a total of four groups, including a cannabis suppository-only group, a mindful-compassion-only group, a combined mindful compassion and cannabis suppository group and a care-as-usual group. #Intervention - BEHAVIORAL : Mindful- compassion - Online mindful-compassion weekly for four weeks - BEHAVIORAL : Mindful-compassion and cannabis suppositories - Cannabis suppositories and online mindful-compassion for vaginal pain

#Eligibility Criteria: Inclusion Criteria: * Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories. * Must have engaged in vaginal sex within the last month * Must be at least 6 months post cancer treatment * Must be based in the United Kingdom * Must have experienced sexual pain * An absence of co-occurring difficulties * Must be aged >= 18 years * Must be able to read and write English. * Patient health screening score must range between 0 <= age <= 9 mild * Generalised anxiety disorder screening score must range between 0 <= age <= 9, mild Exclusion Criteria: * Have not attempted vaginal intercourse in the last month * Have co-occurring difficulties * Are still receiving cancer treatment or within 6 months of cancer treatment such as chemotherapy, surgery or radiation * Aged below 18 years * Reading and writing English difficulties * Not experiencing pain during vaginal sexual intercourse. * Patient health screening score ranged between moderate to severe - 10 <= age <= 27 * Generalised anxiety screening score ranged between 10- 21. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT06607835

{ "NCT_ID" : "NCT03793894", "Brief_Title" : "Inpatient Smokers and LDCT Screening Part 2", "Official_title" : "Engaging Low SES Inpatient Smokers in LDCT Lung Cancer Screening: Enhanced Interventions That Include CHWs to Address SDH Barriers", "Conditions" : ["Lung Cancer Screening", "Smoking Cessation"], "Interventions" : ["Behavioral: CHW Navigation", "Behavioral: Smoking Cessation Counseling", "Behavioral: Decision Aid", "Behavioral: Shared decision making (SDM)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Lung cancer suffers from large racial and socioeconomic disparities. Yet those at the highest risk of lung cancer death - current smokers, blacks, and individuals with low socioeconomic status (SES) and negative social determinants of health (SDH) - are less likely to receive preventive health services, including the two most effective interventions to reduce lung cancer mortality: tobacco dependence treatment and lung cancer screening (LCS) with low-dose computed tomography (LDCT). At Boston Medical Center (BMC) these preventive services are grossly underutilized, in part due to barriers our patients face in accessing these outpatient programs. Innovative approaches are needed to guide high-risk smokers to post-discharge early lung cancer detection services. The overarching goal of this study is to reduce disparities in lung cancer morbidity and mortality by using hospitalization at an urban safety net hospital as an opportunity to connect high-risk smokers to both LDCT lung cancer screening and tobacco dependence treatment. In addition to inpatient shared decision making \[SDM\] by an NP using a decision aid, screen-eligible smokers will also be connected with a community health worker (CHW) to facilitate access to outpatient smoking cessation counseling and LCS (CHW navigation). Detailed Description This study is a randomized controlled trial (RCT) among 128 hospitalized smokers at BMC (64 participants in each of two arms), to assess the effect of inpatient SDM + CHW Navigation (AHRQ LDCT screening decision aid + CHW + SDM discussion + smoking cessation counseling) compared to Enhanced Usual Care (smoking cessation counseling + decision aid) on LDCT screening completion at 3 months, patient knowledge, and smoking cessation at 6 months. The research will meet two specific aims (SA1 and SA2). SA1: To address barriers to engaging smokers in prevention and early detection of lung cancer, a pilot RCT (Pilot Study 2) will be conducted in which screen-eligible hospitalized smokers will be randomized to receive inpatient sdm + CHW navigation (inpatient SDM during smoking cessation counseling visits + CHW navigation to coordinate outpatient tobacco treatment, referral to LCS, and resources to address negative social determinant of health that present barriers to these preventive services) or Enhanced usual care (furnishing of LDCT screening decision aid during inpatient smoking cessation counseling visits). Compared to Enhanced Usual Care, it is hypothesized that inpatient sdm + CHW navigation will increase the number of patients completing LCS (1° outcome) and LCS knowledge, and biochemically validated smoking cessation at 6 months (2° outcome). SA2: To collect stakeholder input to inform future implementation, Fifteen primary care providers (PCPs) will be interviewed to assess their impressions of the intervention, integration into workflow, and barriers to adoption. Fifteen smokers who received the intervention will be interviewed to learn their impressions of its utility and suggestions for improvement. #Intervention - BEHAVIORAL : Smoking Cessation Counseling - All participants will receive inpatient smoking cessation counseling by the tobacco-trained NP. Inpatient smoking cessation counseling is the standard of care at BMC. - BEHAVIORAL : Decision Aid - The AHRQ 'Is Lung Cancer Screening Right for me?' patient decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about tradeoffs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW) - BEHAVIORAL : Shared decision making (SDM) - During the smoking cessation consultation, the nurse practitioner (NP) will conduct SDM, using the 4-page AHRQ 'Is Lung Cancer Screening Right for me?' decision aid as a guide. The purpose of SDM is three-fold: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with Centers for Medicare \& Medicaid Services (CMS) requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context. - BEHAVIORAL : CHW Navigation - The CHW will meet with the participant after the SDM to initiate the coordination of outpatient tobacco treatment, referral to LCS, and resources to address the barriers to preventive services. The CHW will follow patients subjects in the intervention arm for 3 months to help navigate and address negative social determinants of health that are barriers to LCS and tobacco treatment. For patients who agree to screening, the CHW will schedule the appointment, arrange the transportation to appointment, and meet participant at the appointment to facilitate the screening.

#Eligibility Criteria: Inclusion Criteria: * Hospitalized smoker at BMC * Meeting LDCT screening eligibility criteria: (age 55 <= age <= 80 years; >=30-pack years smoking) * Current smoker (> 1 cigarette per day) * Able to speak, read, and understand English * Able and willing to comply with all study protocols and procedures * Having a PCP in the BMC network or one of the affiliated health centers Exclusion Criteria: * Inability to tolerate surgical resection of a lung cancer, as defined by home oxygen therapy (an indicator of severe lung cancer or heart disease) * Active cancer (receiving treatment/new diagnosis) in prior 3 months or advanced stage cancer * Signs and symptoms of lung cancer or prior diagnosis of lung cancer * Already had chest CT (LDCT screening or other chest CT) in the past year * Pregnant Sex : ALL Ages : - Minimum Age : 55 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03793894

{ "NCT_ID" : "NCT00288431", "Brief_Title" : "Safety, Tolerability and Maximum Tolerated Dose of Oral AP23573 in Combination With Doxorubicin (8669-015)", "Official_title" : "A Phase 1B, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability and Maximum Tolerated Dose of Oral AP23573 in Combination With Doxorubicin", "Conditions" : ["Cancer", "Sarcoma"], "Interventions" : ["Drug: ridaforolimus", "Drug: Doxorubicin"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is designed to determine the safety, tolerability and maximum tolerated dose of Oral AP23573 in combination with Doxorubicin Detailed Description The primary objective is to determine the maximum tolerated dose (MTD) of AP23573 in combination with doxorubicin, to characterize the safety profile of AP23573 in combination with doxorubicin, and to examine the pharmacokinetics of AP23573 and doxorubicin when given in combination to patients with advanced malignancies. #Intervention - DRUG : ridaforolimus - Different schedules and routes of administration of AP23573 will be examined. For each schedule, AP23573 + Doxorubicin will be co-administered on Day 1 of a 3-week cycle. AP23573 will be given orally and will range in dose from 10-30 mg per dose. - Other Names : - deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009 - DRUG : Doxorubicin - administered at 60 mg/m2 intravenously every 3 weeks

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years with a histological/cytological diagnosis of advanced tumor, preferentially breast, sarcoma, ovarian, endometrial or other tumor types for which treatment with anthracycline therapy is indicated * Prior cumulative doxorubicin exposure less than 400 mg/m2 * An ECOG performance status of 0 or 1 * Adequate cardiovascular function * Measurable disease according to modified RECIST criteria * Adequate hematological, renal and hepatic functions * Able to understand and give voluntary written informed consent Exclusion Criteria: * Women who are pregnant or lactating * Presence of active brain metastases. Patients with treated brain metastases will be eligible if they are on a stable dose of corticosteroids or are without change in brain disease status for at least 4 weeks following related therapy (e.g., whole brain radiation, surgery) * Prior treatment with CCI-779, rapamycin, or any other mTOR inhibitor * Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of AP23573; the interval is >= 2 weeks for signal transduction inhibitors with a half-life known to be <24 hours, and is >= 6 weeks for nitrosourea or mitomycin. Exception: Concurrent treatment with LHRH agonists is allowed for patients with prostate cancer. * Ongoing toxicity associated with prior anticancer therapy other than alopecia and <= Grade 1 peripheral neuropathy by NCI toxicity criteria * Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ) * Known or suspected hypersensitivity to any excipient contained in the study drug * Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin) * Significant uncontrolled cardiovascular disease * Any active infection requiring prescribed intervention * Any other concurrent illness which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug * Any pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption * Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for >= 2 weeks prior to first planned dose of study drug * Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A) * Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573 Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00288431

{ "NCT_ID" : "NCT00152217", "Brief_Title" : "Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)", "Official_title" : "Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)", "Conditions" : ["Gastric Cancer"], "Interventions" : ["Procedure: Surgery", "Drug: TS-1 (S-1)"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery. #Intervention - DRUG : TS-1 (S-1) - 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks - PROCEDURE : Surgery - Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only

#Eligibility Criteria: Inclusion Criteria: * Age 20 to 80 * Hematopoietic WBC >= 4,000/mm^3 Platelet >= 100,000/mm^3 * Hepatic AST and ALT <= 2.5 times upper limit of normal(ULN) Total bilirubin <= 1.5 mg/dL * Renal Creatinine <=ULN Exclusion Criteria: * Prior anticancer treatment Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00152217

{ "NCT_ID" : "NCT02138955", "Brief_Title" : "A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer", "Official_title" : ": A PHASE Ib DOSE ESCALATION STUDY ON THE SAFETY, TOLERABILITY AND ACTIVITY OF LIPOSOMAL CURCUMIN IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC CANCER", "Conditions" : ["Patients w/Advanced Cancer That Failed Std of Care Therapy"], "Interventions" : ["Drug: Liposomeal curcumin"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin administered intravenously as an 8 hour infusion once weekly for 8 weeks. Detailed Description Patients with solid tumors who either failed to initially respond to approved chemotherapy or who have progressive solid tumor cancers following initial response to approved chemotherapy, are eligible for treatment in this phase 1b trial of ascending doses of intravenous liposomal curcumin following a four week period without previous chemotherapy.The escalating dose range of liposomal curcumin will be from 100mg/M2 to 300 mg/M2 in cohorts of three to 6 patients, and administered over eight hours by a syringe pump weekly for eight weeks. Safety and tolerability will be determined by drug related adverse symptoms(if any), hematologic and serologic signs at each clinic visit and by electronic communication between visits. Pharmacokinetic profiles following infusion of drug will be compared with any adverse changes, and any beneficial subjective or objective responses. When the maximum tolerated dose level is reached in any cohort , another three patients will be accrued at a preceding dose level to assure tolerability in subsequent phase 2 clinical trials. #Intervention - DRUG : Liposomeal curcumin

#Eligibility Criteria: Inclusion Criteria: * Male and Female patients >18 years with a histologically/cytologically confirmed diagnosis of locally advanced or metastatic cancer ,for whom no anti-tumor therapy of proven benefit is available at study enrollment. * ECOG 0 <= age <= 2. * Life expectancy of at least 3 months. * Measurable or non-measurable disease according to RECIST v1.1 criteria. * Patients should have at least one measurable lesion or disease which is non-measurable but can be clearly be evaluated for response. * Adequate bone marrow function as evidenced by an absolute neutrophil count :1500 cell/ul. * Hb greater than 9.5 g/dL and a platelet count greater than 100,000/ uL. * Renal function >50ml/min with estimated creatinine clearance (eCcr) using the Cockcroft-Gault formula or serum creatinine<1.5 mg/dL. * Adequate hepatic function as evidenced by serum total bilirubin <3.0 mg/dL, and AST and ALT less than 5 times the upper limit of normal(ULN). * Signed informed consent. Exclusion Criteria: * Patients with lymphoma, hematological cancer or glioblastoma multiforme. * Active infection, or a fever >38.5C within three days prior to the first day of study drug dosing. * Current or past history evidence of disease (hemolytic diathesis, hemochromatosis) that could be exacerbated by administering liposomal curcumin. * Currently on coumadin or coumadin derivatives(oral anticoagulants), or any medications classified as cytochrome p450 inhibitors or inducers. * Last systemic therapy less than three(3) weeks before (six weeks if treatment was with BCNU or CCNU). * Unresolved toxicities from prior systemic anti-cancer therapy except symptomatic motor or sensory neuro-toxicities NCI-CTC Grade <2. * Clinically significant ECG aberrations according to the discretion of the investigator. * Left ventricular ejection fraction (LVEF) <50%. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02138955

{ "NCT_ID" : "NCT00106691", "Brief_Title" : "Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)", "Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)", "Conditions" : ["Preneoplastic Conditions", "Prostatic Intraepithelial Neoplasia"], "Interventions" : ["Drug: Placebo", "Drug: Toremifene 20 mg"], "Location_Countries" : ["Canada", "Argentina", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN). Detailed Description The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy. #Intervention - DRUG : Toremifene 20 mg - The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days). - DRUG : Placebo - The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

#Eligibility Criteria: Inclusion Criteria: * Give voluntary signed informed consent in accordance with institutional policies * Be male, aged >= 30 years * Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist * Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist * Have a serum PSA of <= 10 ng/mL * Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake * Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication * Have adequate bone marrow, liver and renal function: * White Blood Cell (WBC) Count >= 3,000/mm3; * Platelet Count >= 100,000/mm3; * Bilirubin <= 1.5 mg/dL; * AST and ALT < 2x upper limit of normal; * Serum Creatinine <= 2.0 mg% Exclusion Criteria: * Previous exposure to toremifene citrate * Have evidence of prostate cancer (local, regional and/or distal metastasis) * Have any history of other malignancies (Exceptions include non-melanoma skin cancer or other cancer that has no evidence of tumor reoccurrence 5 years after definitive treatment). * Have active systemic viral, bacterial, or fungal infections requiring treatment * Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol * Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening * Currently taking dutasteride. Subject is eligible if he stops dutasteride for a total washout of 90 days prior to the Screening Visit and agrees not to use dutasteride for the duration of the study. * Have previously taken finasteride for greater than two years * Currently taking finasteride. Subject is eligible if he stops finasteride for a total washout of 30 days prior to the Screening Visit and agrees not to use finasteride for the duration of the study. * Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents for the duration of the study. * Have a history of taking PC-SPES within the past two years. * Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens). Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study. Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day. * Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke * History of chronic hepatitis or cirrhosis Sex : MALE Ages : - Minimum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00106691

{ "NCT_ID" : "NCT00969462", "Brief_Title" : "Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma", "Official_title" : "Association Between Response to Aggressive Chemotherapy and Doxorubicin Pharmacokinetics in Non Hodgkin's Lymphoma Patients", "Conditions" : ["Non-Hodgkin's Lymphoma"], "Interventions" : ["Drug: Doxorubicin"], "Location_Countries" : ["Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment \[complete remission (CR) rate 79% versus 31%, P \< 0.0005, respectively\]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction \[88% vs. 62.5%, P=0.05, for the presence of at least one of them\]. One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0.06). The investigators' lack to approve the previous findings might be explained by the small study group. Detailed Description Aim of the study: To evaluate the association between response to chemotherapy, the degree of myelosuppression and the pharmacokinetics of doxorubicin in non-Hodgkin's lymphoma (NHL) patients. Methods: Study protocol: 1. At diagnosis Demographic and clinical parameters be collected (Appendix 1) 2. At course 2: 1. Doxorubicin will be given by 5-7 minutes infusion before the other medications (Doxorubicin doses will be collected (Appendix 1)) 2. Blood will be sampled in course 2, at: 0 minutes 30 minutes 120 minutes 24 hours Two 2ml EDT tubes will be drawn at each time The tubes will be centrifuged at 3000 RPM for 15 min. Plasma samples will be stored in - 700C 3. At the end of chemotherapy courses the following data will be collected (Appendix 2): 1. Episodes of bone marrow depression (leucopenia, neutropenia) Treatment delays Dose reductions Neutropenic fever 2. Remission status \[Complete remission (CR) - disappearance of clinical signs and symptoms of NHL along with normal laboratory and radiological findings\]. 4. At the end of one year of CR Remission status Number of patients: 30 #Intervention - DRUG : Doxorubicin - measurements of serum Doxorubicin levels

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * Biopsy proven intermediate grade NHL * No previous chemotherapy * At least 4 courses of R-CHOP at maximal doses are planned * An informed consent Exclusion Criteria: * Do not meet all inclusion criteria Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00969462

{ "NCT_ID" : "NCT04293497", "Brief_Title" : "Development of a New Immunochemistry Method Using Antibodies of Proteins Related Pancreatic Cancer", "Official_title" : "Clinical Validation of a New Immunochemistry Method Using Antibody of Methionyl-tRNA synthetase1(MARS1) in the Pancreatic Cancer Cell; Multicenter Prospective Study", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Diagnostic Test: Cytology staining"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Identifying the malignancy of pancreatic mass using endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is important for treatment decision-making and prognosis prediction. The sensitivity of EUS-FNA cytology specimens based on Papanicolaou (Pap) staining is low, which hampers accurate diagnosis of pancreatic mass. We assessed the diagnostic value of immunohistochemical (IHC) and immunofluorescence (IF) staining for methionyl-tRNA synthetase 1 (MARS1). Detailed Description BACKGROUND / AIMS: The sensitivity of endoscopic ultrasound-guided aspiration cytology used to distinguish the pancreatic mass is low and clinical usefulness is not secured. The aim of this study was to evaluate clinical efficacy of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using pancreatic cancer related protein expressed only in pancreatic cancer. Hypothesis: The statistical significance between conventional staining method and MARS1 staining in the pancreatic cancer cells collected by endoscopic ultrasound-guided aspiration will be compared to prove the usefulness of the new staining method. Clinical study design: The expression of MARS1 in the pancreatic cancer cell line obtained by endoscopic ultrasound in patients suspected of having pancreatic cancer using Immunofluorescence or immunohistochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed. #Intervention - DIAGNOSTIC_TEST : Cytology staining - Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained using endoscopic ultrasound-guided fine needle aspiration. Three types of slides (direct smear, thinprep, surepath) are prepared for staining. 1. conventional cytology staining method 2. new cytology staining method using antibody of methionyl-tRNA synthetase 1

#Eligibility Criteria: Inclusion Criteria: * Patients with pancreatic cancer confirmed by imaging (CT, MRI, PET-CT) * Patients with pancreatic cancer diagnosed using cytology by endoscopic ultrasound * Patients who underwent surgical treatment with pancreatic cancer Exclusion Criteria: * Minors under the age of 19, vulnerable subjects such as illiteracy * Excludes necrotic specimens * Samples with non-diagnostic cytology results and insufficient cells for further evaluation * Samples classified as neoplastic (benign or other) Sex : ALL Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04293497

{ "NCT_ID" : "NCT00723086", "Brief_Title" : "Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer", "Official_title" : "An Extension Multicenter Phase II Open Label Non-comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer.", "Conditions" : ["Therapy, Prostatic Neoplasms"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer. #Intervention - DRUG : docetaxel (XRP6976) - combined treatment with prednisolone

#Eligibility Criteria: Inclusion Criteria: Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment. Exclusion Criteria: * Continuation in the study would be detrimental to the patient's well-being * Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing * Obvious disease progression (rising prostate specific antigen, any increase of >= 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion) * Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study Sex : MALE Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00723086

{ "NCT_ID" : "NCT00953277", "Brief_Title" : "Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer", "Official_title" : "A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy", "Conditions" : ["Peripheral Nerve Injury", "Prostate Cancer", "Radical Prostatectomy", "Nerve Reconstruction", "Cavernous Nerve Injury"], "Interventions" : ["Other: Processed Human Nerve Tissue Scaffold"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects. #Intervention - OTHER : Processed Human Nerve Tissue Scaffold - Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

#Eligibility Criteria: Inclusion Criteria: * >= 18 years, but <=70 years; * IIEF EF Domain*1 score >= 22; * be able to effectively communicate with study personnel; * be considered by the physician to be available for subsequent visits; * be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration; * sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and * require radical prostatectomy. Exclusion Criteria: * prior surgery in the last 6 months which could affect sexual function; * history of Peyronie's disease; * significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy); * treatment for major psychiatric disorders; * history of penile implant or prosthesis; * history of diabetic neuropathy; * life expectancy of less than two years; * concurrently involved in another investigational study; * uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening; * currently receiving or planned treatment with chemotherapy or radiation therapy; * diagnosis of bony metastasis; * known allergy or severe intolerance to PDE-5 inhibitors; or * cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00953277

{ "NCT_ID" : "NCT04374825", "Brief_Title" : "Optimizing Quality of Life in Women Living With Metastatic Breast Cancer", "Official_title" : "Optimizing Quality of Life in Women Living With Metastatic Breast Cancer: Feasibility and Preliminary Efficacy of a Tailored, eHealth Supportive Oncology Intervention", "Conditions" : ["Metastatic Breast Cancer"], "Interventions" : ["Behavioral: Cognitive Behavioral Stress Management (CBSM)", "Behavioral: Acceptance and Commitment Therapy (ACT)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what kinds of support women would like to receive in a tailored Acceptance and Commitment Therapy (ACT) intervention. In the second phase of the study, we will conduct a three-arm randomized controlled trial to the tailored ACT intervention with both a Cognitive Behavioral Stress Management (CBSM) intervention and usual care. The CBSM and ACT intervention groups will meet with a trained facilitator and 8-9 other patients, once per week via videoconference for 90 minute sessions over the course of 8 weeks. #Intervention - BEHAVIORAL : Acceptance and Commitment Therapy (ACT) - This intervention consists of 8, 90-minute online group sessions delivered via video conference. Content will be developed by tailoring an ACT intervention to the specific needs of women with MBC, by using qualitative data gathered in patient focus groups. The intervention will incorporate key concepts of ACT (i.e., creating meaning and purpose in life via coping skills, activities in line with patients' values, and mindfulness meditation). - BEHAVIORAL : Cognitive Behavioral Stress Management (CBSM) - This intervention consists of 8, 90-minute online group sessions delivered via videoconference. Content is drawn from a standard published CBSM intervention previously tested in other studies. The intervention incorporates key concepts of CBSM (i.e., managing stress via deep breathing and relaxation, identifying distorted thoughts,cognitive restructuring, and effective interpersonal communication).

#Eligibility Criteria: Inclusion Criteria: * Patients must be diagnosed with metastatic (stage IV [M1]) female breast cancer, via physician diagnosis and confirmed through staff review of electronic medical record (i.e. imaging, surgical pathology reports, etc.). * Patients must be comfortable speaking English for participation in group sessions. * Patients must be age >= 18 years. * Patients taking part in the 8 week online pilot trial must have a physician-anticipated life expectancy of > 6 months. * Patients must have the ability to understand, and the willingness to sign, a written informed consent prior to registration on study. Exclusion Criteria: * Patients who have severe or impairing psychiatric illness/social situations that would limit compliance with study requirements are not eligible to enroll. * Patients with early stage/non metastatic breast cancer (Stages I-III) are not eligible to enroll. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04374825

{ "NCT_ID" : "NCT00089349", "Brief_Title" : "Alemtuzumab With or Without Methotrexate and Mercaptopurine in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia", "Official_title" : "A Phase II Study of Campath-1H in Children With Acute Lymphoblastic Leukemia in Second or Greater Relapse or Twice Induction Failure", "Conditions" : ["Recurrent Childhood Acute Lymphoblastic Leukemia"], "Interventions" : ["Biological: alemtuzumab", "Drug: methotrexate", "Drug: mercaptopurine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial is studying how well giving alemtuzumab with or without methotrexate and mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as methotrexate and mercaptopurine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. Detailed Description PRIMARY OBJECTIVES: I. Determine the response rate to alemtuzumab alone and in combination with methotrexate and mercaptopurine in children with acute lymphoblastic leukemia in second or greater relapse or twice induction failure. II. Determine the toxicity of these regimens in these patients. SECONDARY OBJECTIVES: I. Determine the pharmacokinetics of alemtuzumab in these patients. II. Determine the immune response in patients treated with alemtuzumab. III. Determine changes in the number of CD52-positive cells in the blood and marrow of patients treated with alemtuzumab. IV. Determine the rate and timing of clearance of peripheral circulating lymphoblasts in patients treated with these regimens. OUTLINE: This is a multicenter study. Course 1: Patients receive alemtuzumab IV over 2 hours on days 1-5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR), partial remission (PR), or cytolytic PR at day 29, or patients with CNS disease that achieve a CNS 1 or CNS 2 status, proceed to course 2. Courses 2 and 3: Patients receive alemtuzumab IV over 2 hours on days 1, 8, 15, and 22; methotrexate IV continuously over 24 hours on day 1 and then orally once daily on days 8, 15, and 22; and oral mercaptopurine once daily on days 1-28. Patients with a CR or PR at day 29 proceed to course 3. In course 3, patients receive alemtuzumab, methotrexate, and mercaptopurine as in course 2. CNS prophylaxis\*: Patients receive methotrexate intrathecally on day 1 of courses 2 and 3 on day 1 of courses 2 and 3. NOTE: \* CNS-negative patients receive methotrexate intrathecally on day 15 of course 1 and day 1 of courses 2 and 3. #Intervention - BIOLOGICAL : alemtuzumab - Given IV - Other Names : - anti-CD52 monoclonal antibody, Campath-1H, MoAb CD52, Monoclonal Antibody Campath-1H, Monoclonal Antibody CD52 - DRUG : methotrexate - Given IV - Other Names : - amethopterin, Folex, methylaminopterin, Mexate, MTX - DRUG : mercaptopurine - Given PO - Other Names : - 6-mercaptopurine, 6-MP, Leukerin, MP

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of acute lymphoblastic leukemia (ALL) * Meets 1 of the following criteria: * Second or subsequent bone marrow relapse * Failed >= 2 regimens for remission induction * Patients who relapse while receiving standard ALL maintenance chemotherapy do not require a waiting period prior to study entry * More than 25% blasts in bone marrow aspirate (M3 marrow) * CD52 expression on >= 25% of malignant cells at relapse * Philadelphia chromosome-positive patients must have failed prior imatinib mesylate * Performance status - Karnofsky 50 <= age <= 100% (for patients > 10 years) * Performance status - Lansky 50 <= age <= 100% (for patients <= 10 years) * At least 8 weeks * ALT <= 5 times upper limit of normal (ULN) * Bilirubin <= 1.5 times ULN * Creatinine clearance or radioisotope glomerular filtration rate >= 70 mL/min * Creatinine normal for age * Pulse oximetry > 94% * No evidence of dyspnea at rest * No exercise intolerance * No serious uncontrolled infection * No autoimmune hemolytic anemia * No autoimmune thrombocytopenia * Not pregnant or nursing * No nursing for 3 months after study participation * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * Seizure disorder allowed provided patients are on anticonvulsants and symptoms are well controlled * CNS toxicity <= grade 2 * No other serious uncontrolled medical condition (e.g., diabetes) * Recovered from prior immunotherapy * At least 8 weeks since prior biologic agents (e.g., monoclonal antibodies) * More than 1 week since prior growth factor(s) * At least 4 months since prior stem cell transplantation * No evidence of active acute or chronic graft-versus-host disease post allogeneic stem cell transplantation * No prior alemtuzumab or its components * No other concurrent anticancer immunomodulating agents * Recovered from prior chemotherapy * One dose of prior intrathecal (IT) methotrexate, cytarabine, and hydrocortisone; IT cytarabine alone; or IT methotrexate alone allowed as part of initial diagnostic spinal tap * Prior hydroxyurea therapy allowed * No other concurrent anticancer chemotherapy agents * Prior steroid therapy allowed * More than 2 weeks since prior radiotherapy and recovered Sex : ALL Ages : - Maximum Age : 30 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00089349

{ "NCT_ID" : "NCT01885572", "Brief_Title" : "National, Multicenter PMS Study 'Patient Reported Outcome' in Breast Reconstruction Following Mastectomy With TiLOOP Bra", "Official_title" : "National, Multicenter Post-market Surveillance Study 'Patient Reported Outcome' in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)", "Conditions" : ["Breast Reconstruction After Mastectomy"], "Interventions" : ["Device: TiLOOP Bra"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation. The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra. #Intervention - DEVICE : TiLOOP Bra - Titaniferously coated polypropylene mesh

#Eligibility Criteria: Inclusion Criteria: The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria: Clinical Criteria (reason): * women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant * women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history * the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0 <= age <= 2 Study-related inclusion criteria - Legal reasons: * Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation * Patient information has been handed out and all written consents are at hand. * Patient is between 18 and 70 years. Exclusion Criteria: Patients must be excluded if any of the following conditions exist or cannot be excluded: Device-related exclusion criteria (contraindications): Pathological or physical condition precluding such as: * Pregnancy or breast-feeding patients * Known intolerance to the mesh-implants under investigation. Study-related exclusion criteria - Medical reasons: * metastatic breast cancer * medicamentous regulated diabetes with blood sugar level >250 * inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates < 10000/µl * patient with known contraindication to mesh-implants or plastic-reconstructive breast operations Study-related exclusion criteria - Legal reasons: * Lack of written patients informed consent. * Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol. * Patient is institutionalized by court or official order (MPG§20.3). * Participation in another operative clinical investigation. It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01885572

{ "NCT_ID" : "NCT01999686", "Brief_Title" : "PCOS Treatment Using DLBS3233, Metformin, and Combination of Both", "Official_title" : "Polycystic Ovary Syndrome Treatment Using DLBS3233, Metformin, and Combination of Both, and Its Relation to Fertility", "Conditions" : ["Polycystic Ovary Syndrome (PCOS)", "Insulin Resistance"], "Interventions" : ["Drug: Placebo metformin", "Drug: Placebo DLBS3233", "Drug: Metformin XR", "Drug: DLBS3233"], "Location_Countries" : ["Indonesia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6 months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive parameters. Detailed Description There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following: * Treatment I : DLBS3233 100 mg once daily * Treatment II : Metformin XR 750 mg twice daily * Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily. Laboratory examination to evaluate metabolic efficacy parameters will be performed at baseline, Month 3rd, and end of study (Month 6th). Clinical and laboratory examination to evaluate the reproductive efficacy parameters using trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at baseline to the end of study. Safety examination will be performed at baseline and end of study. Occurrence of adverse event will be observed along the study conduct. #Intervention - DRUG : DLBS3233 - Other Names : - Inlacin - DRUG : Metformin XR - Other Names : - Glumin XR - DRUG : Placebo metformin - Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin). - DRUG : Placebo DLBS3233 - Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).

#Eligibility Criteria: Inclusion Criteria: * Signed written informed consent prior to participation in the study. * Female subjects in reproductive age (i.e. 18 <= age <= 40 years) willing to conceive. * Subject with a diagnosis of polycystic ovary syndrome confirmed by two of the following (Rotterdam Criteria): * Hyperandrogenism (defined by elevated free testosterone concentration; or Ferriman-Gallwey Score of >= 8). * Ovarian dysfunction indicated by menstrual irregularity: oligomenorrhea (cycles of > 35 days), or amenorrhea (no menses in the last of 3 months) after negative screening pregnancy test. * Polycystic ovary as shown by ultrasonography (USG). * Subject with insulin resistance defined by : HOMA-IR of > 2.00. * Subject with body mass index (BMI) of 19 <= age <= 35 inclusive. * Able to take oral medication. Exclusion Criteria: * Pregnant or lactating women (urinary pregnancy test will be applied at screening). * Based on previous or current medical (either laboratory or clinical) examination, subjects known to have any of the following conditions: * Cushing's syndrome, late onset of congenital adrenal hyperplasia, androgen-secreting tumors, uncontrolled thyroid disease, hyperprolactinemia. * Known to have the following medical condition: * Diabetes mellitus, * Uncontrolled hypertension * Symptomatic cardiovascular diseases: * Acute or chronic infections at baseline. * Any known malignancies. * History of gynecological surgery. * Impaired renal function * Impaired liver function * Medically-assisted weight loss with medications or surgical procedures. * Currently having laparoscopic ovarian diathermy (LOD). * Currently under treatment with in vitro fertilization (IVF) techniques. * Have been regularly taking any of the following medications, within <= 3 months prior to screening, such as: * Clomiphene citrate * Insulin sensitizers, i.e. metformin and thiazolidinediones * Aromatase inhibitors, such as: anastrozole, letrozole * Glucocorticoids * Gonadotropins * Gonadotropin-releasing hormone agonists (GnRHa) * Oral contraceptive pills (OCPs) * Antiandrogens, such as: spironolactone, cyproterone acetate (CPA), and flutamide * Any traditional or herbal medicines * Participating in other clinical trial within 30 days prior to screening. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: No

NCT01999686

{ "NCT_ID" : "NCT02962115", "Brief_Title" : "Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention", "Official_title" : "Development and Pilot Testing of a Clinical Informatics Lung Cancer Screening Intervention", "Conditions" : ["Lung Neoplasms"], "Interventions" : ["Behavioral: Decision Aid Invitation"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates the feasibility of a clinical informatics system-based approach to lung cancer screening. Patients of a large academic medical center who may qualify for lung cancer screening will be sent an electronic invitation to complete an online lung cancer screening decision aid. Detailed Description The Center for Medicaid and Medicare Services (CMS) recently approved the use of low-dose chest CT scans for lung cancer screening in patients who meet specific criteria. However, many individuals who meet these criteria do not realize they qualify for screening. This study will determine the feasibility of using a clinical informatics approach to systematically identify potential candidates for LDCT screening, reach out to them via the patient portal, and use a web app to provide them with a personalized LDCT screening decision aid and facilitate the ordering of screening tests. #Intervention - BEHAVIORAL : Decision Aid Invitation - electronic invitation to complete web-based decision aid

#Eligibility Criteria: Inclusion Criteria: * Has an active patient portal account * Scheduled to see a Wake Forest primary care provider within the next 4 weeks Exclusion Criteria: * Never smokers * Current or former history of lung cancer * Receipt of chest CT scan within last 12 months * Need for a language interpreter * Presence of disease predicting short life-expectancy Sex : ALL Ages : - Minimum Age : 55 Years - Maximum Age : 77 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02962115

{ "NCT_ID" : "NCT02444949", "Brief_Title" : "A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma", "Conditions" : ["Nasopharyngeal Neoplasms"], "Interventions" : ["Radiation: intensity modulated radiation", "Drug: endostar", "Drug: cisplatin"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the migration of endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular remodeling and normalization of the tumor vasculature, which will effectively aid the delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with chemoradiotherapy will be a promising way of treatment for NPC. In this study, the first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse effects rate and quality of life. This research will provide more evidences of evidence-based medicine for the safety and tolerability of endostar and the clinical application of endostar in NPC treatment. #Intervention - DRUG : endostar - Other Names : - Human recombinant vascular endothelial inhibitor - RADIATION : intensity modulated radiation - DRUG : cisplatin - Other Names : - DDP

#Eligibility Criteria: Inclusion Criteria: * Age from 18 to 70 ears ; * Eastern Cooperative Oncology Group performance status of 0 <= age <= 1; * diagnosed with first-treated NPC (Ⅲ/Ⅳa stage) confirmed by pathology; * ecurrent and metastatic NPC with indication of chemoradiotherapy; * one measurable lesion at least (according to the RECIST guidelines, the lesion iameter>=20 mm with MRI); * life expectancy of >= 12 weeks; * adequate hematologic, renal, cardiac and liver function; * hemameba>=4.0×109/L; * neutrophil>=2.0×109/L; * platelet>=100×109/L; * hemoglobin>=95g/L; * Serum bilirubin, ALT and AST <=1.5 times of maximum criteria; * sufficiently understand this study situation and signed the informed consent. Exclusion Criteria: * allergy or intolerance to study drugs; * receiving other anti-cancer therapy; * uncontrolled central nervous system lesions; * dysfunction of important organs； * history of cardiovascular disease(including congestive heart-failure, uncontrolled arrhythmia, angina pectoris which require long-term drug treatment, lular heart disease, myocardial infarction and resistant hypertension); * pregnancy or lactation in women; * protracted Infective wound; * history of mental illness which is not easy controlled. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02444949

{ "NCT_ID" : "NCT01046266", "Brief_Title" : "A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma", "Official_title" : "An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma", "Conditions" : ["Head and Neck Cancer"], "Interventions" : ["Drug: cetuximab", "Drug: RO5083945"], "Location_Countries" : ["Netherlands", "Italy", "United Kingdom", "France", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is \<50. #Intervention - DRUG : RO5083945 - 700mg iv weekly - DRUG : cetuximab - 400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses

#Eligibility Criteria: Inclusion Criteria: * adult patients, >=18 years * squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx Exclusion Criteria: * carcinoma of nasal cavity, paranasal sinus and nasopharynx * recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx * known positivity for HIV, hepatitis B and/or hepatitis C infection Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01046266

{ "NCT_ID" : "NCT02575612", "Brief_Title" : "Diagnosis of Pathological Complete Response by Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer", "Official_title" : "Can a Pathological Complete Response in the Breast be Diagnosed by Vacuum-assisted, Ultrasound Guided Minimal Invasive Biopsy After Neoadjuvant Chemotherapy in Breast Cancer Patients? A Proof of Concept From a Prospective Cohort Study", "Conditions" : ["Breast Neoplasms"], "Interventions" : ["Procedure: vacuum-assisted biopsy"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (VAB) to diagnose pathological complete response (pCR=ypT0) in breast cancer patients after neoadjuvant chemotherapy (NACT). Detailed Description Neoadjuvant chemotherapy (NACT) is an increasingly used approach for patients with locally advanced and primarily inoperable breast cancer or for patients with potentially chemosensitive tumors. In clinical routine surgical treatment follows the pre-operative chemotherapy. However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pCR could potentially be spared of surgery in the future. Up to now, prediction of pCR after NACT, i.e. diagnosing a pCR without surgery, is based on tumor biology at diagnosis, the applied NACT regimen and breast imaging results; all with mediocre accuracy. This prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (MIB) might overcome this diagnostic challenge. From September 1st, 2014 to February 15th, 2015 the investigators performed ultrasound guided vacuum-assisted minimal invasive biopsy (VAB) on 50 breast cancer patients after NACT and directly prior to surgery. To analyse VAB pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative VAB). The results were compared to those of the pathological examination of surgical specimen. #Intervention - PROCEDURE : vacuum-assisted biopsy - Ultrasound guided VAB was used directly prior to breast conserving surgery or mastectomy. It was performed by experienced physicians (\> 50 ultrasound guided minimal invasive biopsies per year, \> 500 breast ultrasound examination of the breast per year). The needle was placed below or beside the target lesion according to physician's choice. At least six biopsies should be taken; up to 12 according to the physicians choice. After the VAB a clip marker was placed to highlight the position of the biopsy for specimen radiography and pathology. - Other Names : - VAB, vacuum-assisted minimal invasive biopsy

#Eligibility Criteria: Inclusion Criteria: The investigators included patients * after neoadjuvant chemotherapy (NACT) according to the NACT protocol * with at least one detectable mass / marker after NACT in ultrasound * with cT1c-cT4a-c tumors * after informed consent * with unilateral or bilateral primary breast cancer, confirmed histologically prior to chemotherapy * with known grading, ER/PgR/HER-2neu- and Ki-67 status * with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT * clinical / imaging partial or complete response to NACT Exclusion Criteria: The investigators excluded patients from the study with * NACT <12 weeks because of termination due to progressive disease, massive adverse events or patient wish * non-detectable mass in ultrasound / dislocation of marker (> 10mm distance to the initial lesion) * cT4d stage (inflammatory breast cancer) * M1 stages * stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02575612

{ "NCT_ID" : "NCT00622661", "Brief_Title" : "Carbohydrates and Related Biomarkers", "Official_title" : "A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers", "Conditions" : ["Healthy", "Overweight"], "Interventions" : ["Other: Low Glycemic Load Diet", "Other: High Glycemic Load Diet"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. Detailed Description This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day 'washout' period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend. Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study. #Intervention - OTHER : Low Glycemic Load Diet - consume both high and low glycemic load diets for 28 days each - OTHER : High Glycemic Load Diet - consume both high and low glycemic load diets for 28 days each

#Eligibility Criteria: Inclusion Criteria: * Healthy males and female subjects * Between the ages of 18 to 45 * BMI between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight) * Willingness to refrain from alcohol during the study * Able to come to the FHCRC in Seattle every weekday night for dinner Exclusion Criteria: * Younger than 18 years or older than 45 years. * Do not fit into one of the study weight groups (normal weight and overweight): BMI < 18.5 kg/m2 or > 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2 * Have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease * Taking prescription medications every day (this includes women taking birth-control pills, shots, patch or IUD with hormones) * Diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible) * Currently pregnant or breastfeeding or planning a pregnancy in the next 3 months. * Using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing tobacco). * Using recreational drugs * Drinking the following amount of alcohol almost every day: 2 or more cans/bottles of beer OR 2 or more glasses of wine OR 3 or more ounces of hard liquor. * Inability (e.g., food allergy or intolerances) or unwillingness to consume the foods that are part of the feeding study diet. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT00622661

{ "NCT_ID" : "NCT00100191", "Brief_Title" : "Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids", "Official_title" : "EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids", "Conditions" : ["Menorrhagia", "Leiomyoma", "Uterine Neoplasms"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment. Detailed Description Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good quality randomized controlled trials have been conducted. The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy. Patients were included when they had uterine fibroids and menorrhagia, and were eligible for hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure, quality of life issues, uterine volume reduction, effect on ovarian function and cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1). All patients were followed for two years after treatment. Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and quality of life. #Intervention - PROCEDURE : uterine artery embolization - PROCEDURE : hysterectomy

#Eligibility Criteria: Inclusion Criteria: * Uterine fibroids * Menorrhagia * Scheduled for hysterectomy * Pre-menopausal Exclusion Criteria: * Childwish (planning to conceive) * Pregnancy * Suspected malignancy * Untreated pelvic inflammatory disease (PID) * Clotting disorders * Contrast fluid allergy * Presence of intrauterine device (IUD) * Renal failure (creatinine > 150 mmol/l) Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00100191

{ "NCT_ID" : "NCT03760003", "Brief_Title" : "Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis", "Official_title" : "A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment", "Conditions" : ["Ulcerative Colitis"], "Interventions" : ["Drug: Placebo", "Drug: ABX464 25mg", "Drug: ABX464 100mg", "Drug: ABX464 50mg"], "Location_Countries" : ["Czechia", "Slovenia", "Poland", "Austria", "Serbia", "Slovakia", "United Kingdom", "Belgium", "Ukraine", "Hungary", "Italy", "Germany", "United States", "France", "Belarus", "Spain", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis. Detailed Description This phase IIb study will evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in improving Modified Mayo Score (MMS) in patients with moderate to severe Ulcerative Colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha \[TNF-α\] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment . Eligible patients will be randomized into 4 parallel intervention/treatment groups: 25mg q.d of ABX464, 50mg q.d of ABX464, 100mg q.d of ABX464, or matching placebo and will be treated for 16 weeks. #Intervention - DRUG : ABX464 25mg - ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks - DRUG : ABX464 50mg - ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks - DRUG : ABX464 100mg - ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks - DRUG : Placebo - Two capsules of placebo once daily for 16 weeks

#Eligibility Criteria: Inclusion Criteria: * Men or women age 18 - 75 years; * Diagnosis of moderate to severe active UC (including ulcerative proctitis if proximal extension of disease occurs beyond 10 cm) confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by Modified Mayo Score (MMS) of 5 to 9 inclusive (on a scale of 0 <= age <= 9). Moderate to severe active UC should be confirmed at screening visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0 <= age <= 3); * Patients having either a documented inadequate response, no response, a loss of response, or an intolerance (defined as the occurrence of at least one Adverse Reaction leading to treatment discontinuation) to either immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor [TNF] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Inadequate response, no response, loss of response is defined as: i. Active disease or relapse in spite of thiopurines or methotrexate given at an appropriate dose for at least 3 months (i.e. azathioprine 2 <= age <= 2.5 mg/kg/day or mercaptopurine 1 <= age <= 1.5 mg/kg/day in the absence of leukopenia), and/or ii. Active disease despite corticosteroids treatment (prednisolone up to 0.75 mg/kg/day) over a period of 4 Weeks, and/or iii. Active disease or relapse in spite of adequate treatment (as defined in the SmPC) with tumor necrosis factor [TNF] inhibitors or vedolizumab, and/or iv. Active disease or relapse in spite of adequate treatment with JAK inhibitors over a period of at least 6 Weeks. * Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (<=20 mg/day) or on beclomethasone diproprionate (<=5mg/day) or on budesonide MMX (<=9 mg/day) for at least 2 Weeks prior to the screening visit; * Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit; * Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit; * Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit. Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication; * Patients on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii) must be on stable doses for at least 2 Weeks prior to the screening visit; * Patients on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on stable doses for at least 2 Weeks prior to the screening visit; * Patients who have received tumor necrosis factor [TNF] inhibitors, vedolizumab or other biologics must have discontinued therapy at least 8 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance; * Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance; * Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 Weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight; * Patients with surveillance colonoscopy defined as per ECCO guidelines; * Patients with the following hematological and biochemical laboratory parameters obtained at screening: i. Hemoglobin > 9.0 g dL-1; ii. Absolute neutrophil count >= 750 mm-3; iii. Platelets >= 100,000 mm-3; iv. Total serum creatinine <= 1.3 x ULN (upper limit of normal); v. Creatinine clearance > 90 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline; vi. Total serum bilirubin < 1.5 x ULN; vii. Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 2 x ULN; * Patients are able and willing to comply with study visits and procedures as per protocol; * Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures are performed; * Patients should be affiliated to a social security regimen (for French sites only); * Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 2 Weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with an infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male participants should use condoms and not donate sperm as long as contraception is required. Exclusion Criteria: * Patients with Crohn's Disease (CD) or presence or history of fistula, indeterminate colitis (IC), infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis); * History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or imminent colectomy, colonic malignancy; * History or current evidence of colonic dysplasia or adenomatous colonic polyps. Patient with severe gastrointestinal complications; e.g., short bowel syndromes, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation; * History of more than one episode of herpes zoster or a history (single episode) of disseminated zoster; * Patients with active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), CMV (positive IgM), TB and recent infectious hospitalization; * Patients previously treated with ABX464; * Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history; * Acute, chronic or history of immunodeficiency or autoimmune disease; * History of malignancy excluding patients considered cured (5 years disease free survivors); * Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks prior to baseline; * Pregnant or breast-feeding women; * Illicit drug or alcohol abuse or dependence; * Patients who received live vaccine 30 days or fewer before first dose of study treatment and/or who's planning to receive such a vaccine during the study duration; * Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer and during the study; * Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03760003

{ "NCT_ID" : "NCT03182959", "Brief_Title" : "Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck Squamous Cell Cancer", "Official_title" : "A Phase 0 Study Evaluating the Systemic Bioavailability and Pharmacodynamic Effects of Avmacol® in the Oral Mucosa of Patients Following Curative Treatment for Tobacco-related Head and Neck Cancer", "Conditions" : ["HNSCC", "Head and Neck Cancer", "Head and Neck Squamous Cell Carcinoma", "Tobacco-Related Carcinoma", "Carcinoma in Situ", "Dysplasia", "Hyperplasia", "Premalignant Lesion"], "Interventions" : ["Drug: Avmacol®"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco. There are three main goals of the study: 1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins; 2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood; 3. to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood. Detailed Description This study hypothesizes that nuclear factor erythroid 2-related factor 2 (NRF2) pathway activation in oral epithelium can be induced by administering Avmacol® to patients curatively treated for a first tobacco-related HNSCC. The aim of this Phase 0 clinical study is to determine the oral bioavailability of sulforaphane in the commercially available dietary supplement, Avmacol®, and to determine the level of pharmacodynamic upregulation of NRF2 target gene transcripts that occurs in the oral epithelium of patients who have completed curative treatment for tobacco-related HNSCC, including high grade dysplasia, carcinoma in situ, or invasive carcinoma. #Intervention - DRUG : Avmacol® - Avmacol® tablets - Other Names : - Broccoli Sprout Extract

#Eligibility Criteria: Inclusion Criteria: * Patients must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC). * Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be human papillomavirus (HPV) negative as defined by routine p16 IHC at the local site. * Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy). * Patients may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated. * Patients must have a Karnofsky Performance Status of 80% or higher or an Eastern Cooperative Oncology Group (ECOG) of 0 <= age <= 1 * Current and former tobacco users are eligible. * Able to perform written, informed consent. * Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 Days prior to the first study intervention. * WCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation. Exclusion Criteria: * Patient has a history of another malignancy within 2 years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1 <= age <= 2, N0, M0 differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation. * Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 immunohistochemistry. * Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered. * Participants who have a positive pregnancy test, are pregnant, or breast feeding. * Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential. * Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy. * Chronic anticoagulation with warfarin. Patients on low molecular weight heparin or fondaparinux may be enrolled. * Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 * Chronic use of steroids at immunosuppressive doses. * History of severe food intolerance to broccoli. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03182959

{ "NCT_ID" : "NCT00355316", "Brief_Title" : "A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients", "Official_title" : "Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients", "Conditions" : ["Breast Neoplasms"], "Interventions" : ["Other: Blood draw"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed. #Intervention - OTHER : Blood draw

#Eligibility Criteria: Inclusion Criteria: Inclusion Criteria - Stage IV breast cancer patients * Patient age must be > 21 years. * Patient must have a tissue diagnosis of invasive breast cancer. * Patient must have documented evidence of metastatic disease. * Patient must have measurable lesions. * Patients must be initiating systemic therapy. Patients receiving hormonal therapy, and/or chemotherapy alone or in combination with other therapies are eligible. * Patient must have an ECOG performance status of 0, 1, or 2. * Patient must be available for follow-up. * Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines. * The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix). Inclusion Criteria - Healthy volunteers A volunteer will be eligible for inclusion in this study only if ALL of the following criteria apply: * Volunteer age must be > 21 years. * Volunteer or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines. * Patients with benign breast disease are eligible for enrollment. * The volunteer with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided both of the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patient has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix). Exclusion Criteria: Exclusion Criteria - Stage IV breast cancer patients A patient will be ineligible for inclusion in this study if ANY of the following criteria apply: * No documented metastatic disease. * No measurable lesions. * Bone only and/or brain metastasis. * Patient is not initiating a new regimen of systemic therapy. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT00355316

{ "NCT_ID" : "NCT01384799", "Brief_Title" : "Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer", "Official_title" : "A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer", "Conditions" : ["Head and Neck Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy. #Intervention - DRUG : CUDC-101 - CUDC-101 will be administered as a 1 hour intravenous infusion three times per week for a one week run-in (week -1) and then as part of the combination treatment on weeks 1-7. If the 225 mg/m2 dose is tolerated in the first cohort, the dose will be increased to 275 mg/m2. If the 225 mg/m2 dose is not tolerated, the dose will be decreased to 175 mg/m2. If 175 mg/m2 is not tolerated the dose will be further decreased to 150 mg/m2. - DRUG : Cisplatin - Cisplatin will be administered intravenously at a dose of 100 mg/m2 on days 2, 23 and 44 of the seven week combination treatment course. - Other Names : - cisplatinum, CDDP, Platinol - RADIATION : Radiation Therapy - The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions per week. The gross disease sites will receive 70 Gy in 35 fractions over seven weeks and the subclinical disease sites will receive 56 Gy in 35 fractions, again over seven weeks.

#Eligibility Criteria: Inclusion Criteria: * Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell carcinoma of the head and neck at the following sites: oral cavity, oropharynx, hypopharynx and larynx with either: * Stage IV p16 positive tumors and >10 pack-years smoking history. * Stage III/IV p16 negative tumors, regardless of smoking history. * At least evaluable disease; one measurable site of disease according to RECIST (Version 1.1) criteria (at least 10 mm for conventional CT/MRI or spiral CT scan) is desirable. * Subjects enrolled in the MTD expansion cohort must have at least 1 tumor lesion that is suitable for repeat biopsy (pre- and post-CUDC-101 infusion). * Age >= 18 years * ECOG performance < 2 * Life expectancy >= 3 months * If female, neither pregnant nor lactating * If of child bearing potential, must use adequate birth control throughout the participation in the treatment phase and for 60 days following the last study treatment. * Absolute neutrophil count >= 1,800/µL; platelets >= 100,000/µL; hemoglobin >= 8.0 g/dL, creatinine <= 1.5x upper limit of normal (ULN); total bilirubin <= 1.5x ULN; AST/ALT <= 2 x ULN. * Serum magnesium and potassium within normal limits (may be supplemented to achieve normal values) * Able to render informed consent and to follow protocol requirements. Exclusion Criteria: * Prior radiotherapy to the region of the study cancer or adjacent anatomical sites, or > 25% of marrow-bearing area. * Prior chemotherapy for the current indication. * Prior therapy that specifically and directly targets EGFR, HER2 or HDAC. * Use of investigational agent(s) within 30 days prior to study treatment. * Primary tumor site of nasopharynx, sinuses, or salivary gland. * History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment. * Patients with prolonged QTc Interval >450 msec. * Acquired Immune Deficiency Syndrome (AIDS) or known infection with human immunodeficiency virus (HIV). Testing is not required. * Known history of gastrointestinal bleeding, ulceration, or perforation within 6 months prior to study treatment. * Known history of stroke or cerebrovascular accident within 6 months prior to study treatment. * Symptomatic cardiac conduction abnormality within 12 months prior to study treatment. * Prior history of hearing impairment. * Known history of renal disease or ongoing renal impairment. * Any uncontrolled condition (such as active systemic infection, diabetes, hypertension), which in the opinion of the investigator, could affect the subjects participation in the study. * Prior allergic reaction to cisplatin, carboplatin or other platinum-containing compounds. * Central nervous system metastases. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01384799

{ "NCT_ID" : "NCT04115111", "Brief_Title" : "Diadem to Investigate the Activity and Safety of Durvalumab", "Official_title" : "A Phase II Study to Investigate the Activity and Safety of Anti-PD-L1 Antibody (Durvalumab) In ADvancEd Pretreated Malignant Pleural Mesothelioma - DIADEM Study", "Conditions" : ["Pleura Mesothelioma"], "Interventions" : ["Drug: Durvalumab"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Malignant pleural mesothelioma (MPM) is a cancer with high mortality rate and few therapeutic options.essentially all patients usually progress and die subsequently to a first line therapyl. There is strong evidence that the immune system is deeply involved in the biogenesis of MPM and that an imbalance in pro-inflammatory cytokines and exhausted adaptive T-cell mediated immune response are the main causes of neoangiogenesis, progression and metastatisation processes.Numerous Phase II-III clinical trials are underway evaluating Durvalumab either as monotherapy or combination with evidence of activity in a wide range of solid tumors. Durvalumab has received FDA approval as second line treatment in patients with locally advanced or metastatic urothelial carcinoma. Given these prospects for PD-L1 Ab, a Phase II study is proposed in order to evaluate the activity and safety of Durvalumab in advanced pretreated MPM. Detailed Description Malignant pleural mesothelioma (MPM) is a cancer with high mortality rate and few therapeutic options. Its incidence is growing fast worldwide and is associated with asbestos exposure, a well known cancerogenic factor driving the development of this cancer. Generally MPM is diagnosed at an advanced inoperable stage and most frequently the only therapeutic approach is palliative chemotherapy. Platinum-pemetrexed doublets prolong significantly median overall survival (OS) and median progression free survival (PFS) with respect to platinum alone and are considered the only therapeutic option in a first line setting. Unfortunately, essentially all patients usually progress and die subsequently to a first line therapyl. There is strong evidence that the immune system is deeply involved in the biogenesis of MPM and that an imbalance in pro-inflammatory cytokines and exhausted adaptive T-cell mediated immune response are the main causes of neoangiogenesis, progression and metastatisation processes. Newer immunotherapeutic agents act on regulatory molecules expressed on immune cells in order to increase T cell activity and immune response against tumor. The anti-cytotoxic T lymphocyte antigen 4 (anti-CTLA4) demonstrated activity and a long-term disease control (DC) rate in advanced pretreated MPM in phase II study even if these results are not confirmed in more recently Phase IIb randomized trial versus placebo (DETERMINE study). Antibodies against Programmed Death 1 receptor (PD-1) and its ligand (PD-L1) are highly promising new agents regulating immune check-point processes. In particular the interaction of these agents takes place peripherally more than in the lymphoid tissue and may explain the higher response rate and lower adverse immune effects in comparison to antiCTLA4 agents. AntiPD-L1 antibodies are widely studied in many Phase I-II trials in different advanced pretreated solid tumors independent of tumor PD-L1 expression, with promising results and long-term survival. Ongoing melanoma and lung cancer phase III trials would probably better define the role of this class of drugs in clinical practice. Durvalumab is a human IgG1 antibody which binds specifically to PD-L1, preventing binding to PD-1 and CD80. Numerous Phase II-III clinical trials are underway evaluating Durvalumab either as monotherapy or combination with evidence of activity in a wide range of solid tumors. Durvalumab has received FDA approval as second line treatment in patients with locally advanced or metastatic urothelial carcinoma. Given these prospects for PD-L1 Ab, a Phase II study is proposed in order to evaluate the activity and safety of Durvalumab in advanced pretreated MPM. #Intervention - DRUG : Durvalumab - Durvalumab in monotherapy as second line treatment

#Eligibility Criteria: Inclusion Criteria: * Histological diagnosis of advanced unresectable MPM; * Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 5 unstained slides for central determination of PD-L1 expression; * Aged >= 18 years; * Performance status 0 <= age <= 1 (ECOG); * Measurable disease as defined by Modified RECIST v1.1 for MPM; * One previous chemotherapy line for MPM, based on pemetrexed plus platinum derivative combination; * Previous chemotherapy course concluded at least 4 weeks prior to recruitment; * Signed informed consent; * Negative pregnancy test. All patients in reproductive age or potential must agree to use effective contraception, as defined by the study protocol for the entire duration of treatment with study drug and for 3 months following its interruption; * Patients who have received palliative radiation are eligible if <30% of bone marrow was irradiated and normal hematological function was completely regained; * Adequate organ and marrow function as defined below: Haemoglobin >= 9.0 g/dL, Absolute neutrophil count (ANC) >= 1.5 x 109/L (> 1500 per mm3), Platelet count >= 100 x 109/L (>100,000 per mm3); * Adequate liver function: Serum bilirubin <= 1.5 x institutional upper limit of normal (ULN) (except for patients confirmed Gilbert's syndrome, who will be allowed only in consultation with their physician); AST (SGOT)/ALT (SGPT) <= 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be <= 5x ULN; * Adequate renal function: Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance. Exclusion Criteria: * Radiotherapy with curative intent to thoracic wall (concomitant with or prior to chemotherapy); * Severe concomitant illness; * History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, type I diabetes mellitus, vasculitis, or glomerulonephritis; * Any other anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent); * History of primary immunodeficiency; * HIV( Ab anti HIV+), active TB infection , HBV or HCV infection; * History of allogeneic organ transplant; * History of hypersensitivity to durvalumab or any excipient; * Any condition that, in the opinion of the investigator, would interfere with study treatment or patient safety; * History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated, melanoma stage one, prostate adenocarcinoma, bladder cancer), unless in remission for 3 years or more and judged of negligible potential of relapse; * Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias; * Brain / leptomeningeal involvement; * Any previous treatment with a PD-1 or PD-L1 inhibitor, including Durvalumab; * AEs from prior anticancer therapy that have not resolved to grade <= 1 except for alopecia Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04115111

{ "NCT_ID" : "NCT01125566", "Brief_Title" : "LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment", "Official_title" : "LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment", "Conditions" : ["Breast Neoplasms"], "Interventions" : ["Drug: BIBW 2992", "Drug: vinorelbine", "Drug: trastuzumab"], "Location_Countries" : ["Slovenia", "Ireland", "Peru", "Korea, Republic of", "Portugal", "Germany", "France", "Canada", "Poland", "Sri Lanka", "Turkey", "United Kingdom", "Lithuania", "Mexico", "Singapore", "Egypt", "Austria", "South Africa", "Chile", "Russian Federation", "Belgium", "Australia", "China", "Czechia", "Lebanon", "India", "Israel", "Taiwan", "Brazil", "Netherlands", "Slovakia", "Argentina", "Italy", "United States", "Latvia", "Belarus", "Spain", "Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment #Intervention - DRUG : BIBW 2992 - patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management - DRUG : trastuzumab - patients receive trastuzumab 2mg/kg intravenously every week - DRUG : vinorelbine - patients receive vinorelbine 25mg/m² intravenously every week - DRUG : vinorelbine - patients receive vinorelbine 25mg/m² intravenously every week

#Eligibility Criteria: Inclusion criteria: * Histologically confirmed diagnosis of HER2-overexpression breast cancer * Stage IV metastatic disease * Must have progressed on one prior trastuzumab treatment * no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line) * Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer * Must have (archived) tumour tissue sample available for central re-assessment of HER2-status * At least one measurable lesion according to RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 . Exclusion criteria: * Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab * Prior treatment with vinorelbine * Known pre-existing interstitial lung disease * Active brain metastases * History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation. * Cardiac left ventricular function with resting ejection fraction of less than 50%. * Patients unable to comply with the protocol. * Any contraindications for therapy with vinorelbine or trastuzumab. * Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. * Use of any investigational drug within 4 weeks of randomisation. * Inadequate hepatic, renal and haematologic organ function Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01125566

{ "NCT_ID" : "NCT00574626", "Brief_Title" : "Comparing Autologous Peripheral Blood Stem Cell to Bone Marrow Transplantation for Recurrent Non-Hodgkin's Lymphoma", "Official_title" : "Randomized Trial Comparing Autologous Peripheral Blood Stem Cell Transplantation to Bone Marrow Transplantation for Patients Receiving High-Dose Chemotherapy and Transplantation for Recurrent Non-Hodgkin's Lymphoma", "Conditions" : ["Lymphoma"], "Interventions" : ["Procedure: PBSCT", "Procedure: Bone Marrow Transplant"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with intermediate grade NHL with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our transplant program. Detailed Description These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be stratified according to good and poor prognosis category and relapsed vs. first partial response categories. The patients will have bone marrow or peripheral stem cells collected according to standard protocols. A standardized hematopoietic growth factor will be used for mobilization and post-transplant. The patients' PSC or bone marrow (BM) product will be assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays. The patients' outcome for transplantation will be evaluated with response to transplantation, relapse rates and event free survival being the measured end points. #Intervention - PROCEDURE : PBSCT - Peripheral Blood Stem Cell Transplant - PROCEDURE : Bone Marrow Transplant - Bone Marrow Transplant

#Eligibility Criteria: Inclusion Criteria: * Age 16 <= age <= 65 * Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status > 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. Exclusion Criteria: * Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible. * Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process. * Patients who do not otherwise meet high-dose therapy and transplantation entry criteria. Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00574626

{ "NCT_ID" : "NCT00203372", "Brief_Title" : "Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)", "Official_title" : "A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Placebo 15 and TAC", "Drug: Bevacizumab 7.5 and TAC", "Drug: Bevacizumab 15 and TAC", "Drug: Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)"], "Location_Countries" : ["Ireland", "Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and investigate whether changes in gene expression, or the expression of specific biomarkers, are either predictive of response to bevacizumab or indicative of response. Detailed Description The study combines bevacizumab with a very efficacious combination chemotherapy regimen for the treatment of stage II or stage III primary breast cancer. Safety of the TAC-bevacizumab combination will be evaluated. In addition, the study design incorporates an initial cycle of bevacizumab or placebo alone. Assessing the isolated effects of bevacizumab in a setting where pre- and post-treatment tissue specimens can be obtained will provide essential information about the mechanisms by which VEGF inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of bevacizumab on breast tumor tissue. #Intervention - DRUG : Bevacizumab 7.5 and TAC - Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC). - DRUG : Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) - placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC - DRUG : Bevacizumab 15 and TAC - one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC. - DRUG : Placebo 15 and TAC - one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically proven adenocarcinoma of the breast * Stage II (T > 3 cm) or Stage III disease (except inflammatory breast cancer), according to the AJCC Staging Manual, 6th Edition, 2002 * HER2-negative disease (as defined by fluorescence in situ hybridization [FISH]) * ECOG performance status 0 <= age <= 1 * No prior chemotherapy, radiotherapy, or endocrine therapy for invasive or noninvasive breast cancer * Normal cardiac function (ejection fraction > lower limit of normal) as determined by MUGA or echocardiogram * Adequate organ function Exclusion Criteria: * Prior chemotherapy or radiotherapy for Stage II or Stage III breast cancer * Inflammatory Breast Cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast * Prior treatment with an anti-angiogenic agent * Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer * Bilateral invasive breast cancer * Concurrent therapy with any other non-protocol anti-cancer therapy * Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization) * Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline * Presence of any non-healing wound, bone fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease * History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix * Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication * Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy * Active, uncontrolled infection requiring parenteral antimicrobials * The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications * Pregnancy or lactation * A history of a severe hypersensitivity reaction to bevacizumab, or docetaxel or other drugs formulated with polysorbate 80 * Evidence of bleeding diathesis or coagulopathy * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to beginning therapy * Urine protein:creatinine ratio of > 1.0 at screening Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00203372

{ "NCT_ID" : "NCT01356173", "Brief_Title" : "Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma", "Official_title" : "An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma", "Conditions" : ["Non-Hodgkin's Lymphoma, Solid Tumor"], "Interventions" : ["Drug: GDC-0349"], "Location_Countries" : ["Canada", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO). #Intervention - DRUG : GDC-0349 - Oral escalating dose

#Eligibility Criteria: Inclusion Criteria: * Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit * Evaluable or measurable disease per RECIST v1.1 or IWG response criteria for patients with NHL and/or the following: prostate cancer patients with non-measurable disease are eligible if they have two rising prostate-specific antigen (PSA) levels >= 5 ng/mL measured >= 2 weeks apart that meet the PSA, and Working Group criteria for progression prior to initiation of study treatment, and ovarian cancer patients with non-measurable disease are eligible if they have two rising CA-125 levels greater than the ULN >= 2 weeks apart prior to initiation of study treatment. * ECOG performance status of 0 or 1 at screening * Life expectancy of >= 12 weeks * Adequate hematologic and organ function within 14 days prior to initiation of study treatment * Documented willingness to use an effective means of contraception for both men and women while participating in the study and for 90 days after the last dose of GDC-0349 * Willingness to provide archival tumor tissue Exclusion Criteria: * Leptomeningeal disease as the only manifestation of the current malignancy * History of Type 1 or 2 diabetes requiring daily medication * Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment * Active congestive heart failure or ventricular arrhythmia requiring medication * Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment * Active infection requiring intravenous (IV) antibiotics * Patients requiring any daily supplemental oxygen * Uncontrolled hypomagnesemia or hypokalemia * Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis * Known human immunodeficiency virus (HIV) infection * Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications * Significant traumatic injury within 3 weeks prior to initiation of GDC-0349 * Major surgical procedure within 4 weeks prior to initiation of GDC-0349 * Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment. Kinase inhibitors, approved by national regulatory authorities, may be used up to 2 weeks prior to initiation of GDC-0349, provided that any drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor. * Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349 * Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349 * Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy * Pregnancy or lactation Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01356173

{ "NCT_ID" : "NCT01113476", "Brief_Title" : "Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies", "Official_title" : "Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies", "Conditions" : ["Advanced Cancer"], "Interventions" : ["Drug: Nab-paclitaxel", "Drug: Gemcitabine", "Drug: Bevacizumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The goal of this clinical research study is to find the highest tolerable dose of the combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab) that can be given to patients with advanced cancer. The safety of this drug combination will also be studied. Detailed Description Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of a combination of nab-paclitaxel, gemcitabine, and bevacizumab based on when you joined this study. All participants will receive the same dose level of gemcitabine. However, the first group of participants will receive the lowest dose level of nab-paclitaxel and bevacizumab. Each new group will receive a higher dose for one of the drugs than the group before it, if no intolerable side effects were seen. The other drug may be at the same dose or a lower dose. This will continue until the highest tolerable dose of combination of nab-paclitaxel, gemcitabine, and bevacizumab is found. Up to 15 dose levels of the study drug combination will be tested. Three (3) to 4 participants will be enrolled at each dose level. Once the highest tolerated dose is found, up to 10 more participants will be added at that dose level. This is called an expansion group. Study Drug Administration: On Days 1, 8, and 15 of each 28-day cycle, you will receive nab-paclitaxel and gemcitabine by vein over about 90 minutes total. Also, if the first dose is well tolerated, you may be given the remaining doses of nab-paclitaxel and gemcitabine at home. On Days 1 and 15 of each cycle, you will receive bevacizumab by vein over about 60 minutes. Also, if the first dose is well tolerated, you may be given the remaining doses of bevacizumab at home. Study Visits: Each week during Cycle 1: * Your medical history will be recorded. * Blood (about 2 teaspoons) and urine will be collected for routine tests. * Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You will need to fast for at least 4 hours before this blood draw. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you had any side effects from them. * You will have urine tests performed to check for high levels of protein in your urine (a known side effect of bevacizumab). On Day 1 and 8 of Cycle 1, you will have a physical exam, including measurement of your weight and vital signs. During Week 1 of Cycles 2 and beyond: * Your medical history will be recorded. * You will have a physical exam, including measurement of your weight and vital signs. * Blood (about 2 teaspoons) and urine will be collected for routine tests. * Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You will need to fast for at least 4 hours before this blood draw. * Blood (about 2 teaspoons) will be drawn to see how well your blood clots and how long it takes for your blood to clot. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you had any side effects from them. * Females who are able to become pregnant must have a negative blood (about 1 teaspoon) pregnancy test. During Weeks 2 and 4 of Cycles 2 and beyond: * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you had any side effects from them. * Blood (about 2 teaspoons) will be collected for routine tests. During Week 3 of Cycles 2 and beyond: * Your medical history will be recorded. * You will have a physical exam, including measurement of your weight and vital signs * Blood (about 2 teaspoons) and urine will be collected for routine tests. * Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You will need to fast for at least 4 hours before this blood draw. * Blood (about 2 teaspoons) will be drawn to see how well your blood clots and how long it takes for your blood to clot. * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you had any side effects from them. At the end of every 2 cycles (Cycles 2, 4, 6, and so on), you will have an x-ray, CT scan, PET scan, or MRI scan to check the status of the disease. If you have disease in your bones, a bone scan may also be done. Length of Study: You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur. You may chose to stop taking the study drugs at any time. You should tell the study doctor right away if you are thinking about stopping your participation in this study. The study doctor will talk to you about how to safely stop taking the study drugs. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of certain types of breast cancer, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. Bevacizumab is FDA approved and commercially available for the treatment of colorectal, breast, lung, and brain cancer. Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer. The combination of these drugs is investigational. Up to 120 patients will take part in this study, but this may be increased at a later time. All will be enrolled at MD Anderson. #Intervention - DRUG : Nab-paclitaxel - Starting dose of 50 mg/m\^2 on Day 1, 8 + 15 every 28 days (+/- 2 days) - Other Names : - Paclitaxel, Abraxane, ABI-007 - DRUG : Bevacizumab - Starting dose of 5 mg/m\^2 on Day 1 + 15 every 28 days (+/- 2 days) - Other Names : - Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF - DRUG : Gemcitabine - 1000 mg/kg Day 1, 8 + 15 every 28 days (+/- 2 days) - Other Names : - Gemcitabine Hydrochloride, Gemzar

#Eligibility Criteria: Inclusion Criteria: * Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months. * Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available. * ECOG performance status <= 2 (Karnofsky >= 60%). * Patients must have allowable organ and marrow function defined as: absolute neutrophil count >= 1,000/mL; platelets >=50,000/mL; creatinine <= 3 X ULN; total bilirubin <= 3.0; ALT(SGPT) <= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose. * Ability to understand and the willingness to sign a written informed consent document. * Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies. Exclusion Criteria: * Patients with hemoptysis within 28 days prior to entering the study. * Patients with clinically significant unexplained bleeding within 28 days prior to entering the study. * Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg on medication). * Pregnant or lactating women. * History of hypersensitivity to bevacizumab, murine products, or any component of the formulation. * History of hypersensitivity to gemcitabine. * History of hypersensitivity to nab-paclitaxel or paclitaxel. * Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure. * History of CVA within 6 months. * History of surgery within last 28 days. * Grade 3/4 proteinuria. * Nephrotic syndrome. * Incompletely healed wound. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01113476

{ "NCT_ID" : "NCT03123939", "Brief_Title" : "Phase III B in Acute Lymphoblastic Leukemia", "Official_title" : "Phase IIIb Study for Relapsed/Refractory Pediatric/Young Adult Acute Lymphoblastic Leukemia Patients to be Treated With CTL019", "Conditions" : ["Acute Lymphoblastic Leukemia"], "Interventions" : ["Biological: CTL019"], "Location_Countries" : ["Austria", "Norway", "Belgium", "Italy", "Germany", "France", "Spain", "Canada", "Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a single arm, open-label, multi-center, phase III B study to determine the safety and efficacy of CTL019 in pediatric/young adult patients with r/r B-cell Acute Lymphoblastic Leukemia (ALL). Detailed Description This was a single-arm, multi-centeric Phase IIIb study provided pediatric/young adult patients with r/r B-cell ALL the opportunity to be treated with CTL019. The main purpose of this study was to assess the safety of CTL019 for up to 12 months after the CTL019 infusion. The study had the following sequential phases for all patients: Screening including leukapheresis, Pre-Treatment (Cell Product Preparation and Lymphodepleting Chemotherapy), Treatment and Follow-up, and Long-Term Follow-Up (LTFU). The end of study (EOS) was defined as the last patient's last visit, which was the last patient's Month 12 evaluation, or the time of premature withdrawal. All patients were followed in this study for up to 12 months after the CTL019 infusion. #Intervention - BIOLOGICAL : CTL019 - CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)

#Eligibility Criteria: Inclusion Criteria: Relapsed or refractory B-cell ALL in pediatric or young adult patients: * Second or greater bone marrow relapse. * Any bone marrow relapse after allogeneic SCT and must be >= 4 months from SCT at the time of CTL019 infusion OR * Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR * Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy is contraindicated OR * Ineligible for allogeneic SCT For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of program entry.For relapsed or refractory patients previously treated with blinatumomab, CD19 tumor expression must be demonstrated (via flow cytometry) at Screening. Adequate organ function defined as: * A serum creatinine based on age/gender as follows: Maximum Serum Creatinine (mg/dL). Age Male Female: to < 2 years 0.6 0.6; to < 6 years 0.8 0.8; 6 to < 10 years 1.0 1.0; 10 to < 13 years 1.2 1.2; 13 to < 16 years 1.5 1.4; >= 16 years 1.7 1.4. * ALT <= 5 times the upper limit of normal (ULN) for age. * Bilirubin < 2.0 mg/dL. * Minimum level of pulmonary reserve defined as <= Grade 1 dyspnea and pulse oxygenation > 91% on room air. * Left Ventricular Shortening Fraction >= 28% by echocardiogram, or Left Ventricular Ejection Fraction >= 45% by echocardiogram or Multiple Uptake Gated Acquisition (MUGA). Life expectancy > 12 weeks. Age less than 26 at the time of screening. Karnofsky (age >=16 years) or Lansky (age < 16 years) performance status >= 50 at screening. Patients previously treated with blinatumomab who have detectable leukemia and documented CD19+ expression (via flow cytometry) and confirmed absence of CD19- leukemic blasts at Screening may be included. In this case, at least 1 week washout period must be applied from last dose of blinatumomab to start of leukapheresis. Patients previously treated with blinatumomab with no detectable MRD (i.e. MRD negative demonstrated by leukemic blasts < 0.01%) will be excluded. Must have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site. Patients with active CNS leukemia involvement defined as CNS-3 by CSF findings only are eligible but will have their CTL019 infusion delayed until CNS disease is reduced to CNS-1 or CNS-2 by CSF findings. Patients with other forms of active CNS-3 leukemic involvement such as CNS parenchymal or ocular disease, cranial nerve involvement or significant leptomeningeal disease are not eligible. However, such patients with other forms of CNS-3 leukemic involvement (non-CSF involvement) are eligible if there is documented evidence of disease stabilization for at least 3 months prior to CTL019 infusion. Patients must have no acute/ongoing neurologic toxicity > Grade 1 with the exception of a history of controlled seizures or fixed neurologic deficits that have been stable/improving over the past 3 months. Exclusion criteria Isolated extra-medullary disease relapse. Concomitant genetic syndromes associated with bone marrow failure states: Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded. Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell surface immunoglobulin (sIg) positive and kappa or lambda restricted positivity ALL, with FAB L3 morphology and /or a MYC translocation). Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease. Prior treatment with any gene therapy product. Prior treatment with any anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy, except for patients pre-treated with blinatumomab Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening Human immunodeficiency virus (HIV) positive test within 8 weeks of screening. Presence of grade 2 to 4 acute or extensive chronic GVHD. Uncontrolled acute life threatening bacterial, viral or fungal infection at Screening Investigational medicinal product within the last 30 days prior to screening. Pregnant or nursing women.Women of child-bearing potential and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CTL019 infusion. The following medications are excluded: * Steroids: Therapeutic systemic doses of steroids must be stopped > 72 hours prior to CTL019 infusion. * Allogeneic cellular therapy: Any donor lymphocyte infusions must be completed > 6 weeks prior to CTL019 infusion. * GVHD therapies: Any systemic drug used for GVHD must be stopped > 4 weeks prior to CTL019 infusion to confirm that GVHD recurrence is not observed. * Chemotherapy: * TKIs and hydroxyurea must be stopped > 72 hours prior to CTL019 infusion. * must be stopped > 1 week prior to CTL019 infusion: vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate < 25 mg/m2, cytosine arabinoside < 100 mg/m2/day, asparaginase (non pegylated). * must be stopped > 2 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide, methotrexate >= 25 mg/m2). * Pegylated-asparaginase must be stopped > 4 weeks prior to CTL019 infusion. * CNS disease prophylaxis: CNS prophylaxis treatment must be stopped > 1 week prior to CTL019 infusion (e.g. intrathecal methotrexate). * Radiotherapy * Non-CNS site of radiation must be completed > 2 weeks prior to CTL019 infusion. * CNS directed radiation must be completed > 8 weeks prior to CTL019 infusion. * Anti T-cell antibodies: Administration of any T cell lytic or toxic antibody (e.g. alemtuzumab) within 8 weeks prior to CTL019 is prohibited Other protocol-defined inclusion/exclusion may apply Sex : ALL Ages : - Maximum Age : 25 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT03123939

{ "NCT_ID" : "NCT00312377", "Brief_Title" : "ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer", "Official_title" : "A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC", "Conditions" : ["Non-small Cell Lung Cancer", "Lung Cancer"], "Interventions" : ["Drug: Docetaxel", "Drug: Vandetanib"], "Location_Countries" : ["Vietnam", "Korea, Republic of", "Thailand", "Portugal", "Germany", "France", "Canada", "Turkey", "Mexico", "Singapore", "Greece", "Austria", "Belgium", "China", "Malaysia", "Denmark", "India", "Brazil", "Netherlands", "Argentina", "Italy", "United States", "Indonesia", "Spain", "Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy. This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone. All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer. In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent. Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients. Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing. #Intervention - DRUG : Docetaxel - infusion - Other Names : - TAXOTERE™ - DRUG : Vandetanib - oral - Other Names : - ZACTIMA™, ZD6474

#Eligibility Criteria: Inclusion Criteria: Lung cancer patients who answer true to the following statements are eligible to join this clinical study. * I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV) * I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed. Exclusion Criteria: Lung cancer patients who answer true to the following are NOT eligible to join this clinical study. * I do not have non small cell lung cancer (NSCLC) * I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable. * I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible) * I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted. * I have a history of uncontrolled irregular heartbeat * I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00312377

{ "NCT_ID" : "NCT00619424", "Brief_Title" : "A Phase I Study Of Pazopanib With Either Erlotinib Or Pemetrexed In Patients With Advanced Solid Tumors", "Official_title" : "A Phase I Study of Pazopanib in Combination With Either Erlotinib or Pemetrexed in Patients With Advanced Solid Tumors", "Conditions" : ["Lung Cancer, Non-Small Cell"], "Interventions" : ["Drug: pazopanib", "Drug: erlotinib", "Drug: pemetrexed"], "Location_Countries" : ["Italy", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) of pazopanib in combination with erlotinib (Arm A) or pazopanib in combination with pemetrexed (Arm B) in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 (in each arm) to receive escalating doses of pazopanib and erlotinib or pazopanib and pemetrexed. Dose escalation schemas for each study arm are described in the protocol. For each arm, the MTD regimen will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the MTD regimen to evaluate toxicity and pharmacokinetics. In arm A (erlotinib), a run-in phase with each drug separately will allow an evaluation of pharmacokinetics with each drug separately and also for the two drugs in combination. This will allow an assessment of potential drug-drug interactions. Pharmacokinetic endpoints will be AUC, Cmax, tmax and t1/2 of pazopanib, erlotinib, and pemetrexed, as well as pemetrexed clearance before and after administration of pazopanib in the extension cohort of Arm B. Antitumor activity will be assessed using RECIST criteria. #Intervention - DRUG : pazopanib - Oral tablet administered daily in dosages of 400 - 800 mg. - DRUG : erlotinib - oral tablet taken daily in dosages of 100-150 mg. - DRUG : pemetrexed - IV chemotherapeutic agent administered every 21 days in dosages of 400-500 mg/m2

#Eligibility Criteria: Inclusion Criteria: A subject will be considered eligible for inclusion in this study only if all of the following criteria are met: * Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up. ·Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for Screening or Baseline purposes provided these tests are obtained as specified in the protocol. * Histologically- or cytologically-confirmed diagnosis of advanced solid tumor that has failed standard therapy or for which there is no standard therapy. Subjects for whom erlotinib or pemetrexed are standard therapy may also be entered. * Age >=18 years. * ECOG Performance status must be <=1. * Adequate organ system function as defined in Table 9. System (Laboratory Values) Hematologic: Absolute neutrophil count (ANC) ((>=1.5 X 10^9/L)) Hemoglobin (>=10 g/dL) Platelets (>= 100 X 10^9/L) Prothrombin time (PT) or international normalized ration (INR) (<= 1.2 X upper limit of normal (ULN)) Activated partial thromboplastin time (APTT) (<= 1.2 X ULN) Hepatic: Total bilirubin (<=1.5 X ULN) AST and ALT (<= 2.5 X ULN) Renal: Serum creatinine (<= 1.5 mg/dL) Or, if greater than 1.5 mg/dL Calculated creatinine clearance (<= 50 mL/min) Urine Protein to Creatinine Ratio (UPC)2 < 1 * Subjects may not have had a transfusion within 7 days of screening assessment. * If UPC >= 1, then a 24-hour urine protein must be assessed and 24-hour urine protein must be <1 g protein to be eligible. * Measurable disease on CT scan. * A female subject is eligible to enter and participate in the study if she is of: * Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any woman who has had: * A hysterectomy * A bilateral oophorectomy (ovariectomy) * A bilateral tubal ligation * Is post-menopausal: * Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >=1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40mIU/mL and an estradiol value <40pg/mL (<140pmol/L). * Subjects must discontinue HRT prior to study enrollment due to the potential for inhibition of CYP enzymes that metabolize estrogens and progestins (see Section 8). For most forms of HRT, at least 2 4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female subject is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below. * OR of Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: * An intrauterine device with a documented failure rate of less than 1% per year. * Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female. * Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product. * Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide). Note: Oral contraceptives are not reliable due to potential drug-drug interactions. Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug. A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. * For Arm B (pemetrexed plus pazopanib) subjects: * Must be able to permanently discontinue aspirin dose of >=1.3 g/day for >=10 days before through >=10 days after pemetrexed disodium treatment. All subjects should be able to interrupt intake of NSAIDs with longer half lives (e.g., nabumetone, piroxicam, oxaprozin) for at least 5 days before, the day of, and 2 days following pemetrexed disodium administration. * With mild to moderate renal insufficiency (CrCl from 50 <= age <= 79mL/min) should avoid taking NSAIDs with short elimination half lives (e.g., fenoprofen, indomethacin, ketoprofen, tolmetin, meclofenamate) for a period of 2 days before, the day of, and 2 days following administration of pemetrexed disodium. Exclusion Criteria: * Prior use of pazopanib, erlotinib (for subjects in Arm A), or pemetrexed (for subjects in Arm B). * History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to date of first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required for all subjects. * Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to: * Malabsorption syndrome * Major resection of the stomach or small bowel that could affect the absorption of study drug * Active peptic ulcer disease * Inflammatory bowel disease * Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment. * Presence of uncontrolled infection * Prolongation of corrected QT interval (QTc) > 480 msecs. * History of any one of more of the following cardiovascular conditions within the past 6 months: * Cardiac angioplasty or stenting * Myocardial infarction * Unstable angina * Symptomatic peripheral vascular disease * Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA) * Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140mmHg or diastolic blood pressure (DBP) of >= 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP / DBP values from each blood pressure assessment must be < 140/90mmHg in order for a subject to be eligible for the study. * History of cerebrovascular accident (CVA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti coagulant agents (excluding therapeutic warfarin) for at least 6 weeks are eligible. As noted in Section 8.2, use of therapeutic levels of warfarin must have ended more than 14 days prior to first dose of study drug. * Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. * Evidence of active bleeding or bleeding diathesis. * Hemoptysis within 6 weeks prior to first dose of study drug. * Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. * Is unable or unwilling to discontinue prohibited medications, as listed in Section 8.2, for 14 days or five half-lives (whichever is longer) of a drug prior to the first dose of study drug and for the duration of the study. * Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. * Prior use of an investigational or licensed tyrosine kinase inhibitor that targets VEGF receptors. Note: Prior use of bevacizumab is allowed. * Is now undergoing and/or has undergone in the 28 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy). Note: For prior bevacizumab therapy, at least 40 days should have elapsed between last dose of bevacizumab and first dose of study drug. * Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (with the exception of Grade 2 alopecia) and/or that is progressing in severity. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, erlotinib, or pemetrexed. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00619424

{ "NCT_ID" : "NCT02098291", "Brief_Title" : "An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma", "Official_title" : "Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Drug: G17DT"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer. #Intervention - DRUG : G17DT

#Eligibility Criteria: Inclusion Criteria: * Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent * Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study * Male or female patients > 18 years * Patients with a life expectancy of at least 2 months * Patients must have given written informed consent * Patients with a Karnofsky Performance Status score of >= 50% * Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study) Exclusion Criteria: * History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix * Concomitant use or anticipated use in the period of the study of radiotherapy * Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study * Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids * Females who were pregnant, planning to become pregnant or lactating * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study * Haematological indicators: Haemoglobin <9.5g/dl White blood cell count <3.5 x 109/l Platelets <100 x 109/l Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02098291

{ "NCT_ID" : "NCT01224821", "Brief_Title" : "Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies", "Official_title" : "Multicenter, Phase II Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies", "Conditions" : ["Lymphoma, Non-Hodgkin"], "Interventions" : ["Biological: Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody. #Intervention - BIOLOGICAL : Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab - Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.

#Eligibility Criteria: Inclusion Criteria * Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma or low-grade lymphoma that has transformed to intermediate-, or high-grade lymphoma (transformed lymphoma) according to the Working Formulation for Clinical Usage (IWF A, B, and C). * Patients must have evidence that their tumor tissue expresses the CD20 antigen. * Patients must have progressive disease of either low-grade or transformed lymphoma within one year of completion of the last chemotherapy regimen administered. * Patients must have been previously treated with at least one chemotherapy regimen that included an anthracycline or anthracenedione. * Patients must have a performance status of at least 60% on the Karnofsky Scale and anticipated survival of at least three months. * Patients must have an absolute granulocyte count of over 1,500 /mm3 and a platelet count above 100,000 /mm3 within seven days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products. * Patients must have normal renal function (creatinine less than 2.0 mg/dL) and hepatic function (bilirubin less than 2.0 mg/dL) within seven days of study entry. * Patients must have bi-dimensionally measurable or evaluable progressive lymphoma disease (at least a 25% increase in tumor size or new sites of disease when compared to the last best disease response). Progression must have occurred within 12 months of the preceding response. * Patients must be at least 18 years. * Patients must give written informed consent and sign an approved informed consent form prior to study entry. Exclusion Criteria * Patients with more than an average of 25% of the intertrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically at study entry. * Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within FOUR weeks prior to study entry (six weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of steroids must have been discontinued (except maintenance-dose steroids) at least one week prior to study entry and patients must then show evidence of stable or progressive disease. * Patients with prior hematologic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy . * Patients with obstructive hydronephrosis. * Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry. * Patients with New York Heart Association class 3 or 4 heart disease or other serious illness that would preclude evaluation. * Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for five years. * Patients with known HIV infection. * Patients with known brain or leptomeningeal metastases. * Patients who are pregnant. Patients of child-bearing potential must undergo a pregnancy test within seven days of study entry. Males and females must agree to use effective contraception during the study. * Patients with previous allergic reactions to iodine. This does not include IV contrast materials. * Patients who were previously given any monoclonal or polyclonal antibodies of any foreign species for either diagnostic or therapeutic purposes. This includes engineered chimeric and humanized antibodies. * Patients who previously received radioimmunotherapy. * Patients with progressive disease in a field that has been previously irradiated with more than 3500 cGy. * Patients who are on another protocol involving non-approved drugs or biologics. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01224821

{ "NCT_ID" : "NCT02861222", "Brief_Title" : "Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma", "Official_title" : "Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma", "Conditions" : ["Malignant Glioma"], "Interventions" : ["Drug: Doxorubicin"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days. Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied. #Intervention - DRUG : Doxorubicin - Other Names : - MYOCET

#Eligibility Criteria: Inclusion Criteria: * Patients having received at least one cycle of chemotherapy after radiotherapy * Patients having grade III or IV (WHO) glioma, not localized in brainstem * Tumor measurable with magnetic resonance imaging * Absence of other concomitant anti-cancer treatments * Absence of chemotherapy for 4 weeks; 6 weeks if nitrosourea * Good general health and nutritional status according to NCI-CTC scale (version 3) (appendix 6) * Lansky score > 50% or Karnofsky > 50 in children older than 12 years * Absence of organ toxicity (grade > 2 according to NCI-CTC criteria (version 3) * Hematology: polynuclear neutrophil count > 1.0 x 109/l * Hematology: platelet count > 100 x 109/l * Liver function: bilirubinemia < 1.5 normal value * Liver function: ASAT and ALAT levels < 2.5 normal values * Liver function: prothrombin level > 70% * Liver function: fibrinogen > 1.5 g/l * Renal function: creatinemia < 1.5 normal value/age * Cardiac function: EF > 60% and/or SF > 30% * Signature of informed consent by patient if adolescent, by 2 parents or legal guardian if minor patient * For patients with childbearing potential, a contraceptive method is compulsory. This contraception must be continued 6 months after Myocet treatment end * For patients with childbearing potential, negative pregnancy test (betahCG test) Exclusion Criteria: * Non compliance with eligibility criteria * Severe or life-threatening infection * Non controlled evolutive or symptomatic intracranial hypertension * History of Myocet treatment, but patients could be treated with anthracyclines if cardiac function is normal * Hypersensibility to the active substance, to premixtures or one of excipients * Pregnancy and breastfeeding Sex : ALL Ages : - Minimum Age : 3 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT02861222

{ "NCT_ID" : "NCT01281852", "Brief_Title" : "Paclitaxel, Cisplatin, and Veliparib in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer", "Official_title" : "A Limited Access Phase I Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Veliparib) (NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix", "Conditions" : ["Cervical Adenocarcinoma", "Cervical Adenosquamous Carcinoma", "Cervical Squamous Cell Carcinoma, Not Otherwise Specified", "Recurrent Cervical Carcinoma", "Stage IVB Cervical Cancer AJCC v6 and v7"], "Interventions" : ["Other: Laboratory Biomarker Analysis", "Drug: Veliparib", "Drug: Cisplatin", "Drug: Paclitaxel"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I clinical trial studies the side effects and best dose of veliparib when given together with paclitaxel and cisplatin and to see how well they work in treating patients with cervical cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment or that has come back. Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) and giving chemotherapy together with veliparib may kill more tumor cells. Detailed Description PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities of ABT-888 (veliparib) when combined with cisplatin and paclitaxel in women with advanced, persistent, or recurrent cervical cancer. II. To examine the safety of administering ABT-888 when combined with cisplatin and paclitaxel. III. Once the recommended phase II dose is established, to estimate the efficacy of cisplatin, paclitaxel, and ABT-888 with respect to objective tumor response in patients with advanced, persistent, or recurrent carcinoma of the cervix. SECONDARY OBJECTIVES: I. To examine the effects of this regimen on progression-free survival and overall survival. TERTIARY OBJECTIVES: I. To determine the proportion of patients with advanced, persistent, or recurrent cancer of the cervix whose tumors demonstrate loss of the Fanconi anemia group D2 (FancD2) foci formation. III. To determine the association between loss of FancD2 foci formation and progression-free survival, overall survival, and response in this patient population. OUTLINE: This is a phase I, dose-escalation study of veliparib followed by a phase II study. Patients receive paclitaxel intravenously (IV) over 3 hours on day 1, cisplatin IV over 1 hour on day 2, and veliparib orally (PO) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years. #Intervention - DRUG : Cisplatin - Given IV - Other Names : - Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin - OTHER : Laboratory Biomarker Analysis - Correlative studies - DRUG : Paclitaxel - Given IV - Other Names : - Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat - DRUG : Veliparib - Given PO - Other Names : - ABT-888, PARP-1 inhibitor ABT-888

#Eligibility Criteria: Inclusion Criteria: * Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy; histologic documentation of the original primary tumor is required via the pathology report * All patients in the phase II portion must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measureable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI; measurable disease is not required for participation in the phase I portion of this study * Patients in the phase II portion must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as ?non-target? lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Patients must have a Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2 * Recovery from effects of recent surgery, radiotherapy or other therapy * Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted * At least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone; at least six weeks must have elapsed from the time of any major surgical procedure prior to randomization * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl * Platelets greater than or equal to100,000/mcl * Hemoglobin >= 9 gm/dL * Creatinine less than or equal to institutional upper limit normal (ULN) or calculated creatinine clearance (Cockcroft-Gault) >= 60 ml/min * Calcium, magnesium, phosphate, and potassium levels within institutional normal limits * Bilirubin less than or equal to 1.5 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN * Alkaline phosphatase less than or equal to 2.5 x ULN * Neuropathy (sensory and motor) less than or equal to grade 1 * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * PHASE I: All patients must have received prior chemoradiation * PHASE I: Patients do not need to have measurable disease Exclusion Criteria: * Patients with prior treatment with ABT-888 or other poly adenosine phosphate (ADP) ribose polymerase (PARP) inhibitors * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of the other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients previously treated with chemotherapy for cervical cancer except when used concurrently with radiation therapy and/or as adjuvant therapy * Chemotherapy administered concurrent with primary radiation (e.g., weekly cisplatin) is allowed; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is allowed (e.g., paclitaxel and carboplatin for up to 4 cycles) * Patients may not be receiving any other investigational agents * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in study * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888 * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study * Patients who are unable to swallow medication * Patients who are breast feeding should be excluded Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01281852

{ "NCT_ID" : "NCT00086268", "Brief_Title" : "Non-small Cell Lung Cancer Study US75 (Z-PACT)", "Conditions" : ["Non Small Cell Lung Carcinoma"], "Interventions" : ["Drug: Carboplatin", "Drug: Taxotere", "Drug: zoledronic acid"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions. #Intervention - DRUG : zoledronic acid - DRUG : Taxotere - DRUG : Carboplatin

#Eligibility Criteria: Inclusion Criteria: * Male or Female patients at least of 18 years * Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery * Women must not be pregnant or attempting to become pregnant * Able and willing to sign informed consent Exclusion Criteria: * Patients with cancer that has spread to the bone * Patients with cancer that has spread to the brain who are receiving treatment * Patients with kidney disease * Patients treated with other investigational drugs Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00086268

{ "NCT_ID" : "NCT01736436", "Brief_Title" : "APG101 in Myelodysplastic Syndrome", "Official_title" : "APG101 in Transfusion-Dependent Patients With Low or Intermediate Risk Myelodysplastic Syndrome", "Conditions" : ["Myelodysplastic Syndrome"], "Interventions" : ["Procedure: Blood drawings", "Procedure: Bone marrow collection", "Drug: Treatment with APG101"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary It has been shown in preclinical experiments with bone marrow from patients with myelodysplastic syndrome that APG101 rescues erythrocytes from premature cell death. This is expected to translate in an improved erythropoiesis and ameliorated anemia in MDS patients. APG101 might, therefore, be a valuable addition to current treatments of low- or intermediate MDS patients suffering from anaemia. Transfusion-dependent patients with low or intermediate risk MDS according to WHO Prognostic Scoring Scale (WPSS) can be included in this study. Treatment consists of 100mg APG101 intravenous as a weekly treatment over 12 weeks + 6 months follow up phase. Primary objective of the trial is safety and tolerability of APG101; secondary objectives are * Hematologic, cytologic and cytogenetic response rate using modified International Working Group (IWG) response criteria * Incidence and time to leukemic progression at 37 weeks * OS (Overall survival) at 37 weeks #Intervention - DRUG : Treatment with APG101 - Patients will be treated 12 weeks with 100 mg APG101 intravenous weekly - PROCEDURE : Bone marrow collection - During the study, bone marrow will be collected 4 times to assess study objectives - PROCEDURE : Blood drawings - During the study, blood will be drawn at different time points to assess study objectives

#Eligibility Criteria: Inclusion Criteria: * Signed informed consent * Male and female patients with cytologically or histologically established diagnosis of de novo MDS according to the WHO-classification, either previously treated or untreated, presenting with low or intermediate risk features according to WHO prognostic status scale (WPSS) * Diagnosis of MDS with a medullary blast count of less than 5% has to be established or confirmed by bone marrow morphology * MDS with 5q deletion only if Lenalidomide is not a treatment option * Red blood cell transfusion dependency of at least 4 units of packed red blood cells (PRBC) during the last 8 weeks before inclusion. Only PRBC transfusions given for a Hb level <= 9g/dl or a haemoglobin level > 9g/dl, if clinically indicated (e.g. coronary heart disease, long distance travel), will count. * Patients refractory to Erythropoietin-stimulating agents (ESA) (as assessed after at least 8 weeks of treatment) or with a low possibility to respond to ESA treatment * at least 18 years, smoking or non-smoking, of any ethnic origin * ECOG performance status <= 2 * Suitable veins or existing port system for intra-venous infusion * Adequate contraception Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * MDS with medullary blast count >= 5% * Chronic monomyeloic leucemia (CMML) * Therapy-related / secondary MDS * High-risk karyotype according to WPSS * Patients scheduled for bone marrow or stem cell transplant within the next 6 months * Parallel treatment with ESA or with other experimental therapy * Prior chemotherapy (including Vidaza) * Treatment within the last 6 weeks with histone deacetylase (HDAC) inhibitors or ESAs * Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion * Active uncontrolled infection * HIV, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection * Any other condition / treatment or past medical history of diseases with poor prognosis that, in the opinion of the investigator, might interfere with the study * History of or current drug or substance abuse * History of other (haemato-) oncological disease (except for non-melanoma skin cancer and adequately treated in situ carcinoma of the cervix) * Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study * Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study * Subject is the investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. * Hypersensitivity to recombinant proteins or excipients in the investigational drug * Pregnancy or breast feeding * Vulnerable patients (e.g., minors or persons kept in detention) Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01736436

{ "NCT_ID" : "NCT02112175", "Brief_Title" : "Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM", "Official_title" : "Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: Lenalidomide"], "Location_Countries" : ["Greece", "Belgium", "Italy", "France", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma. After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase. Detailed Description The planned total number of evaluable subjects for PFS was approximately 351 (234 in the lenalidomide treatment arm; 117 in the placebo treatment arm) and the study will be conducted in European countries. However, due to the significant enrollment challenges and the changes in the NDMM treatment practices in subjects who are not eligible for transplant, such as the recent approval of Revlimid in NDMM setting, the DMC recommended to close study enrollment. Study enrollment was closed on 12 October 2015. #Intervention - DRUG : Lenalidomide

#Eligibility Criteria: Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: Related to initial diagnosis and prior Melphalan Prednisone Velcade (MPV) induction therapy * Previously untreated and symptomatic multiple myeloma. * All 3 criteria (Durie, 2003) and at least one of the Creatinine Renal insufficiency Anemia lytic Bone lesions or osteoporosis criteria must be met. * Measurable disease by protein electrophoresis analyses. * All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least Partial Response as best overall response and maintained at Melphalan Prednisone Velcade discontinuation. If a subject achieves Complete Response prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise. * Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6 <= age <= 9 cycles of induction therapy with Melphalan Prednisone Velcade. * Subjects must have cytogenetic (17 p deletion, and 4;14 translocation), β-2 microglobulin and serum albumin (International Staging System) results from their initial diagnosis available at the time of screening. Related to the subject * Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures, * Age >= 65 years: if < 65 years, the subject must be non eligible for stem cell transplantation, * Eastern Cooperative Oncology Group performance status score <= 2, * Able to adhere to the study visit schedules and other protocol requirements, * Females of Childbearing Potential must: 1. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence2 from heterosexual contact. 2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting Investigational Product, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. * Male Subjects must: 1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female or childbearing potential while participating in the study, during dose interruptions and for at least 28 days following Investigational Product discontinuation, even if he has undergone a successful vasectomy. 2. Agree to not donate semen during Investigational Product therapy and for 28 days after end of study therapy. * All subjects must: 1. Have an understanding that the study medication could have a potential teratogenic risk. 2. Agree to abstain from donating blood while taking Investigational Product therapy and following discontinuation of Investigational Product therapy. 3. Agree not to share study medication with another person. 4. All female of childbearing potential and male subjects must be counseled about pregnancy precautions and risks of fetal exposure. Exclusion Criteria: * The presence of any of the following will exclude the subject from the study enrollment: 1. Previous treatment with anti-myeloma therapy other than the required 6 <= age <= 9 cycles of Melphalan Prednisone Velcade induction therapy (does not include local radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]). 2. Subjects who didn't achieve Partial Response or better after getting at least 6 cycles of Melphalan Prednisone Velcade and at the end of Melphalan Prednisone Velcade whatever the overall response are not eligible. 3. Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or desoxyribonucleic acid modulating agents. Subjects who received investigational agents are also excluded. 4. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 5. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 6. Pregnant or lactating females. 7. Any of the following laboratory abnormalities: Absolute neutrophil count < 1,000/L (1.0 x 10*9/L) Untransfused platelet count < 50,000 cells/L (50 x 10*9/L) Serum glutamic oxaloacetic transaminase/alanine aminotransferase or serum glutamic pyruvic transaminase/alanine aminotransferase > 3.0 x upper limit of normal Serum bilirubin levels > 1.5 x upper limit of normal 8. Renal insufficiency (creatinine clearance < 30 mL/min by Cockcroft-Gault method) or actual creatinine clearance result, or renal failure requiring hemodialysis or peritoneal dialysis. 9. Prior history of malignancies including skin cancer, other than multiple myeloma. 10. Prior history of deep venous thrombosis or pulmonary embolus within 3 years of randomization. 11. Subjects who are unable or unwilling to undergo anti-thrombotic therapy. 12. Peripheral neuropathy of > Grade 2 severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. 13. Known Human Immunodeficiency Virus positivity or active infectious hepatitis, type A, B, or C. 14. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis. 15. Prior allogeneic or autologous stem cell transplantation. 16. Significant active cardiac disease within the previous 6 months including: New York Heart Association class II-IV congestive heart failure Unstable angina or angina requiring surgical or medical intervention Myocardial infarction 17. Any condition that confounds the ability to interpret data from the study. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02112175

{ "NCT_ID" : "NCT01295931", "Brief_Title" : "Nuclear and Near-Infrared (NIR) Imaging in Melanoma", "Official_title" : "Diagnostic Nodal Staging for Melanoma With Nuclear and Near-Infrared (NIR) Molecular Optical Imaging", "Conditions" : ["Melanoma"], "Interventions" : ["Procedure: Imaging", "Drug: Indocyanine Green (IC-Green)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Objectives: 1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral) 2. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation. Detailed Description Indocyanine Green Injections: IC-Green Injections: If you are found to be eligible to take part in this study, you will receive a total of 10-16 injections of IC-Green through a needle in your arms or legs, starting in your hands or feet (5-8 on each arm/leg), depending on the location of the tumor. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed. The study doctor will discuss the number of injections that you will receive in more detail. The injections will be given to you before surgery and all injections will be given intradermally (into or between layers of the skin). The IC-Green injections will allow researchers to see how fluid flows through your body during imaging. This information may help future researchers more easily locate lymph nodes in patients scheduled for lymph node surgery. After all of the IC-Green injections have been given, the imaging procedure will begin. To perform the imaging procedures, researchers will use an experimental camera that shines a special red light onto your skin causing the IC-Green to glow when the images are taken. The red light is like the red light in a grocery store scanner. The imaging procedure will take about 1 hour to complete and will be performed before and during the surgery. Before the IC-Green injections and again during the imaging procedure, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second hour. A study staff member will also closely monitor the injection site at these times for possible side effects. A study staff member will call you the next day and ask you to take your temperature. This phone call should last about 10 minutes. Length of Study: After all of the images have been taken, and the follow-up evaluation is complete, your participation in this study will be over. Follow-Up Evaluation: If you spend the night in the hospital after surgery, a study staff member will visit you in person the day after surgery. At this visit, your temperature will be recorded, you will be asked how you are feeling, and if you have experienced any side effects. The visit should last about 10 minutes. If you do not spend the night in the hospital after surgery, you will be contacted by phone the day after the surgery and you will be asked what your current temperature is, how you are feeling, and if you have experienced any side effects. The phone call should last about 10 minutes. This is an investigational study. IC-Green is FDA approved and commercially available for assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography, and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in melanoma patients is investigational. IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or between layers of the skin and the device that is used to give the injections are investigational. The experimental camera, and the images taken with it, are being used for research purposes only and will not be used to manage your treatment. Up to 18 patients will take part in Part 1 of this study. All will be enrolled at MD Anderson. Complete Lymph Node Dissection: If you agree to participate in this part of the study, you will have additional imaging performed before the surgery and again in your follow-up visit. The imaging will be performed at MD Anderson just before the surgery and during your regularly scheduled standard of care follow-up visit about 4-6 months after surgery to learn what the lymphatic channels look like after completely healing from surgery. Before each imaging session, you will receive a total of 10-16 injections of IC-Green through a needle in your arms and hands or legs and feet, (5-8 on each arm/leg), depending on the location of the tumor. Researchers will use the experimental camera to perform the imaging procedure. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed. The imaging procedures will take up to 2 hours to complete each time. For all participants, before the IC-Green injections and again during the imaging procedure, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second hour. A study staff member will also closely monitor the injection site at these times for possible side effects. Length of Study: Your participation will be over after all the images have been taken and the long-term follow-up is complete. This is an investigational study. IC-Green is FDA approved and commercially available for assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography, and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in melanoma patients is investigational. IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or between layers of the skin and the device that is used to give the injections are investigational. The experimental camera, and the images taken with it, are being used for research purposes only and will not be used to manage your treatment. Up to 6 patients will participate in this part of the study. All will be enrolled at MD Anderson. #Intervention - DRUG : Indocyanine Green (IC-Green) - 5 intradermal injections, 25 µg IC-Green in 0.1 mL of saline, in locations on the extremity (i.e. arm or leg) correlating with the tumor draining nodal basin to begin. Corresponding injections performed on the contralateral limbs. - Other Names : - ICG - PROCEDURE : Imaging - Nonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery. - Other Names : - near-infrared, NIR, NIR fluorescence imaging

#Eligibility Criteria: Inclusion Criteria: * Subjects must be 18 years or older * Diagnosis of invasive melanoma with (ARM A) biopsy documenting a T2 (greater than 1 mm thickness) primary tumor undergoing standard of care sentinel lymph node biopsy (SLN) for definitive pathologic staging, OR (ARM B) documented node-positive (stage III) disease undergoing standard-of-care axillary or inguinofemoral lymph node dissection for regional disease control. * Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential. * Female of childbearing potential who agrees to use a medically accepted method of contraception for a period of one (1) month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives such as birth control pills, Depo-Provera, or Lupron Depot) if such is approved by the subject's Oncologist; (ii) barrier methods (such as a condom or diaphragm used with a spermicide, or (iii) an intrauterine device (IUD). Non-childbearing potential is defined as physiologically incapable of becoming pregnant, including any female who is post-menopausal; postmenopausal is defined as the time after which a woman has experienced 12 consecutive months of amenorrhea (lack of menstruation). * For patients undergoing a complete axillary or inguinofemoral lymph node dissection a positive previous sentinel lymph node or a positive fine needle aspirate or core biopsy of their axillary or inguinofemoral lymph nodes. Exclusion Criteria: * Women who are pregnant or breast-feeding. * Persons who are allergic to iodine * A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation. * History of ipsilateral axillary or femoral surgery not including previous sentinel lymph node biopsy procedure. * Persons who do not meet inclusion criteria. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01295931

{ "NCT_ID" : "NCT06172309", "Brief_Title" : "A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors", "Official_title" : "A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic Effect of NTQ1062 Tablets in Chinese Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumors"], "Interventions" : ["Drug: NTQ1062"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, single-arm, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors. The study comprises a dose-escalation phase and a dose-expansion phase. 1. Dose-escalation:using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of NTQ1062 at 20, 50, 100, 200, 300, 400 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). 2. Dose-expansion:the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors, and to identify the recommended phase 2 dose (RP2D). #Intervention - DRUG : NTQ1062 - tablet(s) PO

#Eligibility Criteria: Inclusion Criteria: * Aged at least 18 years, male or female patients. * Patients with histologically and cytologically confirmed, advanced malignant solid tumors who have progressed on standard therapy or for whom no standard therapy exists, or for whom no standard treatment is available. * (Dose escalation phase)Solid tumors that are at least one evaluable per Response Evaluation Criteria in Solid Tumors(RECIST v1.1);(Dose expansion phase)Solid tumors that are at least one measurable per Response Evaluation Criteria in Solid Tumors(RECIST v1.1). * ECOG score is 0 <= age <= 1. * Predicted life expectancy >=3 months. * Patients must have adequate organ function: 1. Absolute neutrophil count (ANC) >= 1.5×109/L, platelet count >= 75×109/L, hemoglobin >= 85 g/L. 2. Liver function: Total bilirubin <= 1.5xULN, AST and ALT <= 3.0xULN (<= 5.0xULN for patients with Patients with hepatic metastases or hepatic carcinoma). 3. Renal function:Creatinine (Cr) <= 1.5xULN or creatinine clearance (Ccr) >= 50 ml/min/1.73m2. 4. Coagulation function: activated partial thromboplastin time (APTT) and INR <=1.5×ULN. * Female patients of child-bearing potential, and all male partners must consent to use a acceptable method of contraception throughout the study period and for 90 days after the last dose of either study drug. * Patients must be signed written informed consent prior to admission to the study. Exclusion Criteria: * Clinically significant abnormalities of glucose metabolism as defined by any of the following: 1. Diagnosis of diabetes mellitus type I. 2. Baseline fasting glucose value of >=8.33 mmol/l (150 mg/dL). 3. Glycosylated haemoglobin (HbA1C) >=8%. * Patients who are still receive anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drug from 4 weeks prior to the first dose. * Patients have received previous treatment with a AKT,PI3K or mTOR inhibitor. * Patients received strong inhibitors and/or inducers of CYP3A4 within 7 days prior to the first dose of study drug. * Active infection requiring systemic treatment. * Active hepatitis B virus infection or hepatitis C virus infection. * History of human immunodeficiency virus infection. * Patient has symptomatic CNS metastases. * History of severe cardiovascular diseases. * Other conditions that the investigator considers inappropriate for participation in this clinical trial Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT06172309

{ "NCT_ID" : "NCT00421174", "Brief_Title" : "Effectiveness of Etanercept for Idiopathic Pneumonia Syndrome Following Stem Cell Transplantation (BMT CTN 0403)", "Official_title" : "A Randomized Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Idiopathic Pneumonia Syndrome Following Allogeneic Cell Transplantation (BMTCTN0403)", "Conditions" : ["Pneumonia", "Idiopathic Pneumonia Syndrome"], "Interventions" : ["Drug: Placebo plus corticosteroid", "Drug: Etanercept"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The study is designed as a Phase III, multi-center randomized, double-blind, placebo-controlled trial investigating the use of etanercept for the treatment of acute, non-infectious pulmonary dysfunction (IPS) occurring after allogeneic hematopoietic cell transplantation (HCT). Detailed Description BACKGROUND: Over the last two decades, allogeneic hematopoietic cell transplantation (HCT) has emerged as an important treatment for a number of malignant and non-malignant disorders. Unfortunately, several complications, including graft-versus-host disease (GVHD) and pulmonary dysfunction, limit the utility of this aggressive form of therapy. Infectious and non-infectious lung complications occur in 25% to 55% of HCT recipients and account for up to 50% of transplant-related mortality. In about half of affected patients, no infectious organisms are identified in the lungs. Two major types of non-infectious pulmonary injury are recognized: acute idiopathic pneumonia syndrome (IPS) and sub-acute lung injury (obstructive airway disease or bronchiolitis obliterans \[BrOb\] and restrictive lung disease). The current study will examine the use of etanercept in patients with IPS. DESIGN NARRATIVE: Eligible patients will be randomized to receive one of two arms of therapy: (A) etanercept plus corticosteroids, or (B) placebo plus corticosteroids. Patients will receive a total of eight doses of etanercept (or placebo) over a 4-week period. The initial dose of etanercept (or placebo) will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. The placebo will be the inert diluent used for the etanercept formulation. Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated. Chest radiographs shall be obtained weekly through Day 28. Plasma cytokine profiles will be obtained on Days 0, 7, and 28. For patients \< 30 days post-transplant: If the patient's clinical condition is such that a broncho-alveolar lavage (BAL) is deemed 'not possible to be performed' by the treating physician (or pulmonologist), then the 'on study' BAL may be waived. In such circumstances, the patient may register and be randomized to study therapy without the BAL being undertaken. For patients not on mechanical ventilation: If a BAL is not done, appropriate virology studies on a nasal swab (or nasal washing) are required as a minimum procedure to study entry. For patients on mechanical ventilation: Microbiologic studies of a deep endotracheal aspirate are allowed in lieu of a formal bronchoscopy procedure. However, no protocol-specified biologic studies (see Section 4.4) will be done on these specimens. For patients 31-180 days post-transplant: An 'on study' bronchoscopy is required in all cases. If, at any point following initiation of study drug therapy, previously obtained BAL fluid cultures or other BAL fluid analysis become positive for an infectious pathogen, study drug therapy shall be discontinued at that point, and not re-instituted. The patient will discontinue study drug therapy, but will still be followed for outcome. The primary study endpoint is response at Day 28. Patients who discontinue study drug therapy for any reason will still be followed for primary and secondary study endpoints. #Intervention - DRUG : Etanercept - Etanercept will be given eight doses of study drug over a 4-week period. The initial dose of etanercept will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated. - Other Names : - Enbrel® - DRUG : Placebo plus corticosteroid - Patients will receive a total of eight doses of placebo over a 4-week period. The initial dose of placebo will be administered intravenously on Day 0, with subsequent doses administered subcutaneously (SQ). Dosing will be administered twice weekly over 4 consecutive weeks. The placebo will be the inert diluent used for the etanercept formulation. Additionally, patients in both arms will receive corticosteroids (2 mg/kg/day) Day 0 through Day 7, with subsequent taper as clinically indicated. - Other Names : - Methylprednisolone

#Eligibility Criteria: Inclusion Criteria: Patients fulfilling the following criteria will be eligible for registration in this study: * Recipient of an allogeneic bone marrow, cord blood, or peripheral blood stem cell transplant. There are no restrictions based upon underlying disease, donor source, degree of human leukocyte antigen (HLA) match, intensity of the pre-transplant conditioning regimen, or the use of a prior donor leukocyte infusion * Evidence of acute lung injury, based upon the presence of bilateral pulmonary infiltrates (on chest radiograph) and a supplemental oxygen requirement * No more than 180 days post transplant Patients fulfilling the following criteria will be eligible for random assignment in this study: * BAL fluid negative for pathogenic microorganisms as assessed by gram stain and fungal stain * BAL fluid negative for pathogenic microorganisms, or test result pending, as assessed by the following tests: 1. Acid fast bacilli stain (AFB) 2. Bacterial culture (a quantitative culture of at least 10(4) CFU/mL is considered positive) 3. Viral cultures for respiratory pathogens, including Respiratory syncytial virus (RSV), adenovirus, parainfluenza, influenza A and B, and Cytomegalovirus (CMV) 4. Fungal and mycobacterial cultures 5. Pneumocystis carinii pneumonia (PCP) assay, by polymerase chain reaction (PCR), direct fluorescent antibody (DFA) stain, or cytology (per institutional guidelines) Exclusion Criteria: * Sepsis syndrome or hypotension in which inotropic support (excluding dopamine of no more than 5 mcg/kg/minute) is required * Bacteremia within 48 hours prior to study registration * Documented invasive fungal or systemic viral infection (excluding asymptomatic viruria) within 14 days prior to study registration * Evidence of CMV infection, based upon an abnormal PCR assay, antigenemia assay, or shell vial culture within 14 days of study registration * On mechanical ventilation for more than 48 hours at study registration * Evidence of congestive heart failure by clinical assessment * Participating in other investigational studies (Phase I, II, or III) for the treatment of acute GVHD within 7 days of study registration (patients enrolled in BMT CTN 0302 are ineligible for study entry) * Received etanercept within 14 days prior to study registration * Pregnant or breastfeeding * On more than 2 mg/kg/day of methylprednisolone equivalent for more than 48 hours, within 7 days prior to study registration * Known hypersensitivity to etanercept * History of active tuberculosis (TB) infection * History of chronic active hepatitis B or hepatitis C infection * Patients who have undergone a BAL within 72 hours of study registration are ineligible if the BAL fluid is known to be positive for pathogenic microorganisms * Patients who have relapsed or have developed progressive disease post-transplant Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00421174

{ "NCT_ID" : "NCT03048474", "Brief_Title" : "Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma", "Official_title" : "Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma: a Phase II Study. Acronym: INITIATE", "Conditions" : ["Malignant Pleural Mesothelioma"], "Interventions" : ["Drug: nivolumab and ipilimumab"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a prospective, monocenter, single arm, phase II trial in 33 patients with unresectable MPM, who experience disease progression or recurrence after at least one previous line of platinum-based systemic treatment. Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21 thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 2 years or until disease progression or unacceptable toxicity occurs. Detailed Description Patients will undergo pre- and post-treatment thoracoscopies/biopsies. #Intervention - DRUG : nivolumab and ipilimumab - Other Names : - BMS-936558 and L01XC11

#Eligibility Criteria: Inclusion Criteria: * Signed informed consent form * Age >= 18 years * WHO-ECOG performance status 0 or 1 * Able to comply with the study protocol, in the investigator's judgment * Patients with histologically confirmed diagnosis of the recurrence of MPM. Any pleural MPM subtype is permitted for inclusion in the study * Progressive disease after at least one prior systemic treatment with a platinum-based doublet (both cisplatin and carboplatin are allowed) for unresectable MPM. All prior cytotoxic toxicities must have resolved to grade <= 1 prior to registration * Measurable disease on CT scan, according to modified RECIST Criteria for Mesothelioma (Byrne MJ, 2004) * Life expectancy >= 12 weeks * Adequate hematologic and organ function, defined by the following laboratory results, obtained within 14 days prior to the first study treatment: * Absolute neutrophil count (ANC) >= 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1) * WBC count >= 3000 cells/µL * Lymphocyte count >= 250 cells/µL * Platelet count >= 100.000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1) * Hemoglobin >= 5.6 mmol/L * Serum albumin >= 25 gr/L * AST, ALT and alkaline phosphatase <= 2.5 x ULN, with the following exceptions: patients with documented liver or bone metastases: alkaline phosphatase <= 5 x ULN * Serum bilirubin <= 1.5 x ULN Patients with known Gilbert disease who have serum bilirubin level <= 3 x ULN may be enrolled * INR and aPTT <= 1.5 x ULN Patients receiving therapeutic anticoagulation should be on a stable dose Creatinine clearance >= 45 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration or Modification of Diet in Renal Disease formulae may be used; 24-hour urine collection is not required * Women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus) and men with partners of childbearing potential, must agree to use adequate contraception (double barrier birth control) for the whole duration of study treatment and for 3 months after the last dose of therapy * Women of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior the first dose of treatment Exclusion Criteria: * Medical or psychological impediment to comply with the protocol * Patients with only peritoneal MPM * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for at least five years * Concomitant participation in another clinical trial (by the investigator's judgment) * Uncontrolled pleural/peritoneal effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Uncontrolled tumor-related pain Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment. * Previous treatment with any checkpoint inhibitor * Pregnant or lactating women * Patients with brain metastases * History of or active autoimmune disease (e.g. pneumonitis; rheumatoid arthritis; severe form of psoriasis; uncontrolled type I diabetes or hypothyroidism) * History of idiopathic pulmonary fibrosis (including pneumonitis) or unresolved drug-induced pneumonitis, organizing pneumonia, or active pneumonitis on screening chest CT scan * History of relevant gastrointestinal disease, including, but not limited to, Crohn's disease, ulcerative colitis, recurrent diverticulitis * Prior allogenic bone marrow transplantation or prior solid organ transplantation * History of HIV * Patients with history of HBV infection are eligible if serological profile is compatible with past/resolved infection (defined as negative HBsAg test and positive antibody to HBV core antigen [anti-HBc] antibody test) and HBsAg test and HBV-DNA are both negative prior to Cycle 1, Day 1 * Patients with history of HCV infection must be screened for HCV-RNA PCR test prior to Cycle 1, Day 1, and are eligible if the test turns negative * Other serious concomitant disease, including: Active tuberculosis Severe infections within 4 weeks prior to Cycle 1, Day 1 Significant cardiovascular disease (NYHA class III or IV), myocardial infarction within the previous 6 months, unstable angina, or unstable arrhythmias Significant pulmonary (asthma or COPD) or hepatic disease or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment * Major surgical procedures within 28 days prior to Cycle 1, Day 1 * Concurrent medications Treatment with systemic immunosuppressive medications, including but not limited to prednisone (with specific exceptions; see below), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed. The use of systemic prednisone at the dosage of 10 mg/day or lower (or equivalent) is allowed. * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03048474

{ "NCT_ID" : "NCT00072722", "Brief_Title" : "Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)", "Official_title" : "Phase II Randomized Open-Label, Two-Arm Study of Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)", "Conditions" : ["Prostate Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Phase II randomized open-label, two-arm study of safety and efficacy of CC-4047 in subjects with metastatic hormone refractory prostate cancer (HRPC) #Intervention - DRUG : CC-4047

#Eligibility Criteria: Inclusion Criteria: * Understand and voluntarily sign an informed consent form * Adult male subjects, age >= 18 years at the time of signing the informed consent form * Able to adhere to the study visit schedule and other protocol requirements * Histologically confirmed adenocarcinoma of the prostate with radiographic evidence of metastases and PSA progression following hormonal therapy for metastatic disease. Subjects must have evidence of progression of disease as demonstrated by 2 consecutive rises in PSA (an absolute change of at least 1ng/ml) separated by at least 28 days. * Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to entering study with evidence of a rising PSA (from baseline) measured x 2 at least 2 weeks apart Testicular androgen suppression must be maintained with either LHRH therapy of bilateral orchiectomy. * Must use barrier contraception (latex condom) when engaging in reproductive activity with women of child-bearing potential throughout the course of study treatment and for 4 weeks following the discontinuation of study treatment. * May have had only one prior regimen of chemotherapy for prostate cancer. The chemotherapy must have been stopped at least 4 weeks prior to study entry. * Disease-free of other malignancies for greater than 5 years with the exception of curatively treated basal cell, squamous cell carcinoma of the skin of Ta transitional cell carcinoma of the bladder. * ECOG performance status of 0 or 1. * Serum creatinine greater than or equal to 2.0 mg% * Adequate hematologic functions: Granulocytes greater than or equal to 1800 mm3 and platelets greater than or equal to 100,000 mm3. * Adequate hepatocellular function: AST<2 x normal and bilirubin<1.5mg/dl * No active unresolved infection Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret data from the study. * Use of any other experimental drug or therapy within 28 days of baseline. * Any prior use of CC-4047 of Thalidomide * Tumors containing small cell or sarcomatoid elements * Symptomatic bone metastases. * Concurrent use of any other anti-cancer agents. * Known brain disease that is symptomatic, is currently being treated with corticosteroids, or has not been previously irradiated. * Non-PSA producing tumors Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00072722

{ "NCT_ID" : "NCT01072890", "Brief_Title" : "Temsirolimus and Pazopanib in Patients With Advanced Solid Tumors", "Official_title" : "Phase I Study of the Combination of Temsirolimus (CCI-779) and Pazopanib (GW786034) in Patients With Advanced Solid Tumors", "Conditions" : ["Solid Tumors"], "Interventions" : ["Drug: Temsirolimus, Pazopanib"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test the safety of temsirolimus and pazopanib at different doses. Patients who have an advanced cancer that is not felt to benefit from standard treatment or are no longer responding to other treatment will be asked to take part in this study. The study hypothesis is that temsirolimus and pazopanib can be administered safely in combination and that combined targeting of the mammalian target of rapamycin (mTOR) and vascular endothelial growth factor receptor (VEGFR) signaling pathways will be effective in treating patients with advanced solid tumors. Detailed Description Despite encouraging clinical activity reported with single-agent VEGF inhibitors, mTOR inhibitors, and other novel agents, patients rarely achieve complete disease response and ultimately undergo disease progression. The limited efficacy of single-target inhibition may be due to numerous, overlapping signaling pathways involved in Renal Cell Carcinoma proliferation and growth. A strategy of multi-target 'vertical inhibition' of the overlapping aberrant VEGF and mTOR pathways by combination therapy may translate to enhanced efficacy over each single agent alone. We hypothesize that temsirolimus and pazopanib can be administered safely in combination and that combined targeting of the mTOR and VEGFR signaling pathways will be effective in treating patients with advanced solid tumors. #Intervention - DRUG : Temsirolimus, Pazopanib - Patients will be treated on an outpatient basis with both temsirolimus and pazopanib. All patients will receive temsirolimus intravenously (IV) weekly days 1, 8, 15, and 22. Patients will receive oral pazopanib on a daily basis starting day 1. Treatment will be administered on 28 day cycles. Patients will be in this study for a minimum of 8 weeks or 2 cycles. - Other Names : - Torisel, Votrient

#Eligibility Criteria: Inclusion Criteria: * Must have histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective. * Age >= 18 years * Zubrod (ECOG) Performance Status 0 - 2 * May have measurable or non-measurable disease. * Adequate bone marrow and organ function as assessed by the following within 14 days prior to registration. * Any number of prior chemotherapy regimens is allowed. * Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects (except alopecia, lymphopenia and hyperglycemia) resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy. * Pregnant or nursing women are ineligible because of the risk to the fetus. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent. * Ability to swallow and retain oral medications. Exclusion Criteria: * Prior treatment with an mTOR inhibitor or pazopanib. * Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months. * Symptomatic or uncontrolled brain metastasis. * Must have a EKG within 14 days of registration and a QTc of < 480 msec. If the initial QTc is > 480 msec, two subsequent EKGs should be obtained within 5 minutes. * Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. * Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C due to the immunosuppressive effects of temsirolimus. * Active clinically serious infection > CTCAE Grade 2. * Fasting cholesterol > 350mg/dL and fasting triglycerides > 400mg/dL * Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. * Pulmonary hemorrhage/bleeding event >= CTCAE Grade 2 within 4 weeks of first dose of study drug. * Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 4 weeks of first dose of study drug. * Serious non-healing wound, ulcer, or bone fracture. * Evidence or history of bleeding diathesis or coagulopathy. Therapeutic anticoagulation with warfarin, heparin or low molecular weight heparin is not allowed. Patients may not have had an arterial thrombotic event within the past 6 months. * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug. * May not take known strong CYP3A4 inducers such as rifampin or St. John's wort or strong CYP3A4 inhibitors such as ketoconazole, diltiazem, or verapamil. * Known or suspected allergy to temsirolimus or pazopanib, any similar agents such as the rapamycin analog sirolimus, or any agent given in the course of this trial. * Any condition that impairs patient's ability to swallow whole pills. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01072890

{ "NCT_ID" : "NCT00509860", "Brief_Title" : "Irinotecan (Camptosar) in Patients With Advanced Sarcomas", "Official_title" : "A Phase II Study of Irinotecan (Camptosar) in Patients With Advanced Sarcomas", "Conditions" : ["Sarcoma"], "Interventions" : ["Drug: Irinotecan"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary Objectives: 1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma. 2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population. Detailed Description Irinotecan is a chemotherapy drug that fights cancer by interfering with the cancer cells' ability to divide and grow. Before treatment starts, you will be asked questions about your health and have a complete physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have computed tomography (CT) scans and x-rays to check on the status of the disease. If your doctor feels it is necessary, you may also have a magnetic resonance imaging (MRI). Women who are able to have children must have a negative blood or urine pregnancy test. During treatment, you will receive irinotecan by vein over one hour, once a day for 5 days in a row. This will be followed by 2 days of no study drug treatment, then 5 more days of treatment with irinotecan. This 12-day period will be followed by 9 days of rest (no study drug). This 21-day period is called a cycle of therapy. You will continue to receive treatment (cycles repeated) as long as the disease does not get worse or until maximal shrinkage of the cancer. Treatment may be taken on an outpatient basis. During treatment, you will have blood collected (1-2 teaspoons) once a week for routine tests. At least once every cycle of treatment (3 weeks) you will have a physical exam and be asked questions about you health. After the first 2 cycles, the disease will be re-evaluated. You will have blood tests (1-2 teaspoons), x-rays, and CT scans. If your doctor feels it is necessary, you may also have a MRI. This re-evaluation will be repeated every 4 cycles. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. Your doctor may choose to follow up with long-term exams at his/her discretion. This is an investigational study. Irinotecan is FDA approved and is commercially available. Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson. #Intervention - DRUG : Irinotecan - 16 mg/m2 by vein Daily Over 1 Hour x 5 Days - Other Names : - Camptosar, CPT-11

#Eligibility Criteria: Inclusion Criteria: * Patients of all ages. * Patients must have histologic proof of a sarcoma. * Patients must have locally advanced / metastatic disease that is inoperable or incurable with surgery. * If patient has a history of prior malignancy, there must be histologic documentation that metastatic disease is sarcoma. * Patients must have received or refused standard chemotherapy for disease. * Patients must have at least one lesion that is clearly defined, measurable or objectively evaluable. This lesion cannot have been previously irradiated unless progression has been demonstrated after radiation. * Patients must have a life expectancy of at least 12 weeks and a Zubrod performance status of < 2. * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital. The only approved consent form is appended to this protocol. * Patients must receive no other concurrent chemotherapy or immunotherapies. Patients must have recovered from any previous chemotherapy. They must have been off treatment at least 4 weeks from the previous chemotherapy (6 weeks for stem cell toxins) and have recovered from any side effects or toxicity prior to the institution of irinotecan. * Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte counts of at least 1000/cubic mm and platelet count of at least 50,000/cubic mm determined within 2 weeks prior to the first treatment. * Patients should have adequate hepatic function with a bilirubin < 2 times the upper limit of normal, and Serum glutamic pyruvic transaminase (SGPT) < 3 times the upper limit of normal determined within 2 weeks prior to the first treatment. Exclusion Criteria: * Pregnant or lactating women will be excluded, due to unknown side effects on the fetus. * Patients with severe pulmonary insufficiency will be excluded. * Patients of childbearing potential not willing to utilize birth control during and for at least 3 months following completion of the trial shall not be eligible. * Patients with an overt psychosis or mental disability, those with psychological or social situation that would interfere with study follow-up, or otherwise incompetent to give informed consent shall be excluded from the study. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00509860

{ "NCT_ID" : "NCT01056523", "Brief_Title" : "Use of Ribavirin and Low Dose Ara-C to Treat Acute Myeloid Leukemia", "Official_title" : "A Phase I/II Study of Ribavirin and Low-dose Cytarabine Arabinoside (Ara-C) in Acute Myeloid Leukemia (AML) M4 and M5 Subtypes, and AML With High eIF4E Expression", "Conditions" : ["Acute Myeloid Leukemia"], "Interventions" : ["Drug: Cytarabine arabinoside", "Drug: Ribavirin"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to determine the maximum tolerated dose of ribavirin, when given in combination with low-dose ara-C and to determine if it is safe and well-tolerated in patients with acute myeloid leukemia. Detailed Description Primary Objectives In the Phase I portion of this study, we will determine the maximum tolerated dose and recommended phase II dose (RP2D) of ribavirin and low-dose ara-C. The primary objective of the Phase II portion of the study is to determine the overall response rate, including the complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial remission (PR) or blast response (BR), to therapy with ribavirin and low dose ara-C at the RP2D. STUDY DESIGN AND DURATION This is a multicentre, open-label, single arm Phase I/II study of oral ribavirin and low-dose ara-C for patients with AML M4/M5 or AML with high expression of eIF4E, who have relapsed or refractory disease, or who are not suitable candidates for induction chemotherapy. This study will determine the recommended phase II dose and will evaluate efficacy. Correlative studies will be included to assess relevant molecular targets. #Intervention - DRUG : Ribavirin - Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID - DRUG : Cytarabine arabinoside - Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts. - Other Names : - Ara-C

#Eligibility Criteria: Inclusion Criteria: * The following patients with acute myeloid leukemia (AML) are eligible: * De novo AML M4 or M5 FAB subtype or high eIF4E. * Secondary AML after a myelodysplastic syndrome (MDS) or a myeloproliferative disorder (not chronic myelogenous leukemia), if M4 or M5 FAB subtype or high eIF4E. * Therapy-related AML if M4 or M5 FAB subtype or high eIF4E. * CML blast crisis if they have failed imatinib and at least one other tyrosine kinase inhibitor. * All patients must have failed primary therapy (defined as two induction chemotherapies), have relapsed, or are not suitable candidates for intensive induction chemotherapy. * Patients who have a dry aspirate or extramedullary disease only are eligible for this study if they have a pre-treatment marrow or tissue biopsy demonstrating AML M4 or M5 subtype or high eIF4E expression. * ECOG performance status 0, 1, 2 or 3. * Life expectancy > 4 weeks. * Age is > 18 years. * Female patients of childbearing potential must have a negative serum (beta-HCG) pregnancy test within 14 days of starting protocol and must not be breastfeeding. Men and women of childbearing potential must agree to use an effective means of contraception throughout the study and for at least 30 days after completion of protocol. * Adequate renal and hepatic function: serum creatinine < 1.5 x ULN; AST or ALT < 2.5 x ULN (or < 5 x ULN if liver involvement with leukemia); serum bilirubin < 1.5 x ULN. * Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained. * Accessible for treatment and follow up. Exclusion Criteria: * Uncontrolled central nervous system involvement by AML. * Active cardiovascular disease as defined by New York Heart Association (NYHA) class III-IV categorization. * Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up. * Received any previous therapy for AML within 28 days prior to the study entry. Hydrea is permitted for the treatment of leukocytosis but must be stopped within 7 days of starting low dose ara-C and ribavirin. * Female patients who are pregnant or breastfeeding. * Concurrent treatment with other anti-cancer therapy. * Known infection with HIV. * History of other malignancy. Subjects who have been disease-free for 2 year or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * FAB AML M1, 2, 6, 7 will be excluded if they do not have high eIF4E expression. AML M3 is always excluded. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01056523

{ "NCT_ID" : "NCT02141906", "Brief_Title" : "A Pilot Study of 'OncozeneTM' Microspheres for Intra-arterial Delivery of Doxorubicin", "Official_title" : "A Pilot Study of 'OncozeneTM' Microspheres for Intra-arterial Delivery of Doxorubicin for the Treatment of Patients With Unresectable Hepatocellular Cancer", "Conditions" : ["Hepatocellular Cancer"], "Interventions" : ["Other: Oncozene-DEB-TACE"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a pilot study of Onconzene Microspheres for intra-arterial delivery of doxorubicin for the treatement of patients with unresectable hepatocellular cancer. Detailed Description The study will evaluate the safety and tolerability of doxorubicin loaded ONCOZENE microspheres chemoemobilization for the treatment of unresectable hepatocellular carcinoma. The study will also describe the overall response rates of lesions with Oncozene-DEB-TACE(Trans-arterial chemoemobilization) per modified RECIST criteria (Response Evaluation Criteria in Solid Tumors). Determine progression free survival (PFS) and overall survival (OS) following Oncozene-DEB-TACE (Trans-arterial chemoemobilization) #Intervention - OTHER : Oncozene-DEB-TACE - ONCOZENE microspheres are the newly available microspheres for DEB-TACE. It appears (based on the preliminary bench tests) that these microspheres may allow more efficient drug loading, and slow elution and equivalent vascular occlusion(12). In this pilot study, we aim to assess the safety of these microspheres when used for chemoembolization of unresectable hepatocellular carcinoma. - Other Names : - Oncozene microspheres for Doxurubicin delivery

#Eligibility Criteria: Inclusion Criteria: * Patients must have a diagnosis of Hepatocellular carcinoma confirmed by at least one of the following: a) histological confirmation; b) imaging results consistent with cirrhosis and at least one solid liver lesion of >2cm with early enhancement and delayed washout (AASLD criteria for diagnosis of HCC); c) Alpha fetoprotein level >400ng/mL and evidence of at least one solid liver lesion >2cm, regardless of specific imaging characteristics on MRI. * Tumor not suitable for resection at the time of study entry. (Transplant eligible patients are allowed) * Age >= 18 years. * Performance status ECOG PS 0 <= age <= 1 (Eastern Cooperative Oncology Group Performance Status). * Child Pugh Score A only * Adequate organ and marrow function as defined below: * leukocytes >= 3,000/mcL (Measurement and Calibration Lab) * absolute neutrophil count >= 1,500/mcL * platelets >= 75,000/mcl * total bilirubin <= 3.0 * AST (Aspartate Aminotransferase)(SGOT)/ALT (Alanine Aminotransferase)(SPGT) <= 5 X institutional upper limit of normal * creatinine <= 2.0 * INR (International Normalized Ratio) <= 1.8 * Albumin >= 2.8 * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Absence of occlusive thrombus in the main portal vein * Life expectancy of at least 6 months * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those with residual treatment related toxicity of greater than grade 1 not addressed in inclusion criteria. * Any concurrent therapy for HCC including concurrent investigational agents. * Subjects with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or other agents used in study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. * Child-Pugh status B or C * Encephalopathy no adequately controlled medically * Known cardiac ejection fraction <50% * Tumor involving >50% of the liver * Infiltrative form of HCC on imaging; If there is at least one measurable lesion per mRECIST criteria and otherwise patient is eligible for the study, the patient can be enrolled. * Extensive extrahepatic spread of hepatocellular carcinoma. Patients with limited metastatic disease may be enrolled as defined as * lymph node disease * pulmonary nodules <5 mm in size * 1 <= age <= 3 bone metastases * Active gastrointestinal bleeding * Evidence of uncontrollable bleeding diathesis * Any contra-indication to angiography * Any known contra-indication to chemoembolization according to the treating physician Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02141906

{ "NCT_ID" : "NCT01625351", "Brief_Title" : "A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas", "Official_title" : "A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas", "Conditions" : ["Ewing Sarcoma", "Gastrointestinal Tumor", "Germ Cell Tumor", "Hepatic Tumor", "Lymphoma", "Wilms Tumor", "Rhabdoid Tumor", "Clear Cell Carcinoma", "Renal Cell Carcinoma", "Melanoma", "Neuroblastoma", "Rhabdomyosarcoma", "Non-rhabdomyosarcoma"], "Interventions" : ["Biological: stem cells", "Drug: Busulfan", "Drug: sirolimus", "Drug: alemtuzumab", "Drug: melphalan", "Drug: fludarabine", "Device: CliniMACS"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients. Detailed Description Twelve participants and 12 donors will be enrolled on this study. Donors will undergo seven days of hematopoietic stem cell (HSC) mobilization followed by two apheresis collections. Each apheresis collection will be processed by the CliniMACS system. DONORS: A mobilization regimen of granulocyte colony stimulating factor (G-CSF) will be used to obtain a peripheral blood stem cell (PBSC) product from the donor. Apheresis will be performed for a minimum of two consecutive days, including one day for each cell product delivered. STUDY PARTICIPANTS: Participants will undergo a two-stage haploidentical cell infusion following myeloablative conditioning. The first cell infusion will be a CD3-depleted product and the second infusion will be a CD45RA-depleted product. Primary Objective: * To determine the feasibility of haploidentical HSCT using two infusions engineered by negative selection on the Miltenyi CliniMACS system- the first by selective depletion of CD3+ cells, followed by a second depleted of CD45RA+ cells, in children with relapsed or refractory solid tumors or lymphomas. Secondary Objectives: * To estimate hematopoietic cell recovery and engraftment rates for the patients. * To estimate infection rates and complications. * To estimate the one-year overall survival (OS) and event-free survival (EFS) for the study patients. #Intervention - DRUG : alemtuzumab - Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation). - Other Names : - CAMPATH-1H, Campath(R) - DRUG : fludarabine - Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.) - Other Names : - Fludara(R) - DRUG : sirolimus - Patients receive sirolimus beginning on day -1 with taper beginning on day 90. (Day 0 = stem cell transplantation.) Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy. - Other Names : - Rapamycin, Rapamune(R) - DRUG : Busulfan - Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.) - Other Names : - Busulfex(R), Myleran(R) - DRUG : melphalan - Patients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.) - Other Names : - L-phenylalanine mustard, phenylalanine mustard, L-PAM, L-sarcolysin - BIOLOGICAL : stem cells - Patients undergo CD3 depleted haploidentical hematopoietic stem cell transplant (HSCT) on day 0. Patients also undergo CD45RA depleted HSCT infusion on day 1. (Day 0 = stem cell transplantation.) - Other Names : - HSCT, Stem cell transplantation - DEVICE : CliniMACS - The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells. - Other Names : - Cell Selection System

#Eligibility Criteria: Inclusion Criteria - Transplant Recipients: * At least 2 years and less than or equal to 21 years. * Histologically confirmed solid tumor or lymphoma at original diagnosis: * Ewing Sarcoma Family of Tumors (ESFT) * Gastrointestinal tumors * Germ Cell tumors * Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma) * Lymphoma (including Hodgkin and non-Hodgkin lymphoma) * Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and renal cell carcinoma) * Melanoma * Neuroblastoma * Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma) * Malignancy has no reasonable expectation of cure with available alternative salvage therapy. * Has a suitable human leukocyte antigen (HLA) haploidentical donor available. * At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy. * Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the PI. * Shortening fraction greater than or equal to 25%. * Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50 mL/min/1.73 m2. * Pulse oximetry greater than or equal to 92% on room air * Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3 times the upper limit of the institution-established normal range. * Direct bilirubin less than or equal to 3.0 mg/dL. * Karnofsky or Lansky performance score of greater than or equal to 50. Exclusion Criteria - Transplant Recipients: * Newly diagnosed patients with no prior attempt at curative therapy. * Any primary or active central nervous system (CNS) malignancy, including metastatic disease. * Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy. * Prior allogeneic hematopoietic stem cell transplant. * Prior autologous stem cell transplant within previous 3 months. * Allergy to murine products or positive human anti-mouse antibody (HAMA). * (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment). * (Female only) Breast feeding. Inclusion Criteria - Donors: * At least 18 years. * Partially HLA matched family member. * Human immunodeficiency virus (HIV) negative. Exclusion Criteria - Donors: * (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment). * (Female only) Breast feeding. Sex : ALL Ages : - Minimum Age : 2 Years - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01625351

{ "NCT_ID" : "NCT02775318", "Brief_Title" : "Stellate Ganglion Block Using Ultrasound Guidance For Treatment Of Post Clipping Cerebral Vasospasm", "Official_title" : "Efficacy Of Ultrasound Guided Stellate Ganglion Block To Relieve Vasospasm Following Clipping Of Cerebral Aneurysm", "Conditions" : ["Cerebral Vasospasm"], "Interventions" : ["Procedure: Digital Subtraction Angiography", "Procedure: Stellate Ganglion Block", "Drug: Bupivacaine", "Procedure: Transcranial Doppler"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The present study has been designed to assess the efficacy and safety of Stellate Ganglion Block (SGB) in relieving symptomatic cerebral vasospasm following aneurysmal clipping. The effect was assessed by both Digital Subtraction Angiography(DSA) and Transcranial Doppler (TCD). Detailed Description Anesthesiologist was informed about the patients (Post clipping for cerebral aneurysm) having neurological deterioration (hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of ≥ 2 points on the Glasgow Coma Scale(GCS) and in whom the duration of symptoms lasted for at least 1 hour. Anesthesiologist was also informed if increased cerebral blood flow velocity was found on routine daily Transcranial Doppler(TCD) evaluation of such patients. A cerebral Computed tomography(CT) scan was performed at this time to rule out ventricular dilation or any other focal brain lesion explaining the clinical symptoms. In such patient Central venous pressure(CVP) was maintained at 8-10 mm of Hg and systolic blood pressure was maintained between 160-200 mm Hg (using infusion of vasopressors such as phenylephrine or dopamine if required). Oral/ nasogastric nimodipine (60 mg 4 hourly) was continued and hemoglobin was maintained at ≥ 10 gm/dl. Diagnosis Of Vasospasm By Transcranial Doppler A 2 megahertz (MHz) transcranial Doppler ultrasound probe was used to insonate vessels through the temporal acoustic window. Extracranial Internal Carotid Artery (ICA) was insonated in the neck using a linear probe of 8- 13 MHz. Using Transcranial Doppler (TCD) probe, a tracing of waveform of Middle Cerebral Artery (MCA) was identified and confirmed using standard criteria. Peak Systolic Velocity and Mean Flow Velocity were assessed. Pulsatility Index and Resistivity Index were assessed. LINDEGAARD ratio was calculated. Diagnosis Of Vasospasm By Digital Subtraction Angiography (DSA) Patients were shifted to Digital subtraction Angiography room and an emergency cerebral angiographic study was performed using Philips Allura Xper FD20/10 machine. Vasospasm was diagnosed on DSA and the vessel diameter was measured at the mid A1 segment of Anterior cerebral artery(ACA) and mid M1 segment of Middle Cerebral Artery (MCA). Vasospasm was classified as mild (\<25%), moderate (25% to 50%), or severe (\>50%) with respect to two - dimensional diameter at the mid A1 and mid M1 segment of ACA and MCA respectively. Location of vasospasm was classified as unilateral vs bilateral, single vessel involvement vs multiple vessel involvement or diffuse vasospasm (bilateral with multiple vessel involvement). Parenchymal filling time was calculated as the time delay between initiation of contrast injection till the appearance of parenchymal blush. Venous sinus filling time was calculated as the time delay between the initiation of contrast injection till the appearance of superior sagittal sinus. After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 ml of 0.5% Injection Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit. Ultrasound Guided Stellate Ganglion Block - Technique Patients were kept supine with the neck in slight hyperextension. Under aseptic conditions, transducer is placed on the surface of the neck at the level of Cervical (C6) vertebrae. The internal jugular vein, carotid artery, thyroid gland, trachea, C6 vertebrae, transverse process of C6, esophagus, longus colli with its covering prevertebral fascia and esophagus are visualized. The transducer was pressed between the trachea and the carotid artery to retract the artery laterally as well as to position the transducer near the longus colli. A 25-gauge Quincke spinal needle was inserted paratracheal towards the middle of the longus colli muscle. The endpoint of the injection was the ultrasound image of the tip of the needle as it penetrates the prevertebral fascia covering the longus colli muscle. The drug is then injected and spread of drug is visualized as distension of prevertebral fascia around the longus colli muscle in real time. Post Block Assessment- • Development of ipsilateral Horner Syndrome at 5 minutes interval till 30 minutes after block to confirm successful Stellate Ganglion Block. At thirty minutes after the block the following parameters are assessed:- * Neurological condition (GCS score, motor deficits, aphasia, apraxia, hemianopia or neglect). Assessment was done by a blinded neurosurgeon. * Hemodynamic parameters: heart rate, blood pressure * Transcranial doppler measurement of flow velocity in MCA, Pulsatility index(PI), Resistivity Index(RI) and LINDEGAARD ratio. * Digital subtraction angiography was repeated to measure diameter of the vessels affected by vasospasm, change in grading of vasospasm, any increase in vessel diameter, parenchymal filling time and venous sinus filling time. Any increase or decrease in parenchymal and venous sinus filling time was noted. Block Failure- Block was considered a failure if no signs of Horner's syndrome appeared after 30 minutes of SGB block. Ineffective Stellate ganglion block- Block was considered ineffective after 30 minutes of Stellate ganglion block * If there was no neurological improvement * No improvement in Transcranial doppler findings to normal level or no significant change in affected vessel diameter, grading of vasospasm, parenchymal filling time and venous sinus filling time in second Digital subtraction angiography Rescue Management In case of ineffective block, patients were given intra-arterial nimodipine at rate of 0.1 milligram / minute for a maximum dose of 3 milligram /artery as a rescue measure. Following this improvement, these patients were monitored in Intensive care unit(ICU). Management Of Patient In Intensive Care Unit * Avoidance of hypotension. Maintenance of Systolic Blood Pressure(SBP) at 160-200 mm of Hg using vasopressor {(phenylephrine 2-17microgram/Kg/min) and/or (dopamine-5-10 microgram/kg/min)} * Avoidance of hypovolemia, maintain Central venous pressure at 8-10 mm of Hg * Maintenance of Hemoglobin ≥ 9gram/decilitre * Oral/nasogastric Nimodipine 60mg 4 hourly. Clinical course of patients was followed. Baseline neurological, hemodynamic and TCD parameters were reassessed by the anesthesiologist at 30 minutes . Patients with effective block were reassessed for neurological status and flow velocity measurements by Transcranial Doppler at 6 hours, 12 hours, 24 hours, 36 hours and 48 hours after Stellate ganglion block. Patients with ineffective block who received rescue management were not reassessed for neurological status and flow velocity measurements using Transcranial Doppler at various intervals by the anesthesiologist. However the complications occurring in them, the duration of their stay in the hospital and the final outcome in the form of discharge or death was noted. Complications Of Stellate ganglion block Procedure and drug-related complications were noted. Complications During Hospital Stay Complications occurring in the post Stellate Ganglion Block period during the entire hospital stay other than those due to the stellate ganglion block per se were noted. Duration of hospital stay was also noted. #Intervention - PROCEDURE : Stellate Ganglion Block - Under aseptic conditions, transducer is placed on the surface of the neck at the level of C6 vertebrae. The internal jugular vein, carotid artery, thyroid gland, trachea, C6 vertebrae, transverse process of C6, esophagus , longus colli with its covering prevertebral fascia and esophagus are visualized. A 25-gauge Quincke spinal needle was inserted paratracheal towards the middle of the longus colli muscle. The endpoint of the injection was the ultrasound image of the tip of the needle as it penetrates the prevertebral fascia covering the longus colli muscle. The drug is then injected and spread of drug is visualized in real time. - DRUG : Bupivacaine - 10 ml of 0.5% injection bupivacaine is used for giving stellate ganglion block on the side of cerebral vasospasm - Other Names : - Sensorcaine, Marcaine - PROCEDURE : Transcranial Doppler - The principle on which the TCD works is that with arterial narrowing, the blood flow velocity within the vessel increases. A good correlation has been found between the TCD blood flow velocities and vasospasm. The MCA velocity greater than 120 cm/sec indicates mild vasospasm , velocity greater than 130 cm/sec indicates moderate vasospasm and velocity greater than 200 cm/sec indicates severe vasospasm. - PROCEDURE : Digital Subtraction Angiography - Digital subtraction angiography is a direct method for the assessment of vessel caliber. It generates high resolution, high contrast and low artifact images using digital subtraction technology. Direct visualization using DSA is the gold standard for the radiographic diagnosis of cerebral vasospasm - Other Names : - DSA

#Eligibility Criteria: Inclusion Criteria: * Any patient with post aneurysm clipping having symptomatic vasospasm i:e new onset of focal neurological impairment such as hemiparesis, aphasia, apraxia, hemianopia, or neglect or decrease of at least 2 points on the Glasgow Coma Scale (GCS) and duration of symptoms lasting for at least 1 hour. * Transcranial doppler confirmation of vasospasm by measuring cerebral blood flow velocity in MCA and LINDEGAARD ratio. * Cerebral angiographic confirmation of the presence of vasospasm by Digital subtraction angiography Exclusion Criteria: * New onset of focal neurological deficit or deterioration in the level of consciousness due to other causes like re-bleeding, hydrocephalus, cerebral edema, electrolyte disorder, infection and seizure. * Patients having an infarct on cerebral tomography. * Patients with clipping of more than one aneurysm. * Patients with bilateral neurological deficits. * History of allergy to local anaesthetic agents. * Refusal of consent. * Deranged coagulation profile. * Patients with pre-existing pupillary changes where assessment of effectiveness of Stellate ganglion block will be difficult. * History of allergy to contrast media. * Derangement of renal parameters Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT02775318

{ "NCT_ID" : "NCT01222286", "Brief_Title" : "Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma", "Official_title" : "Multicenter Phase II Study on the Anti-tumor Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Fully Human Monoclonal Anti KIR Antibody, in Patients With Smoldering Multiple Myeloma (KIRMONO)", "Conditions" : ["Smoldering Multiple Myeloma"], "Interventions" : ["Drug: IPH2101"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma. Detailed Description This is a randomized Phase II, open label, multi-centre study, with two independent arms. Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization) administered over one hour infusion at four weeks intervals. A patient whose disease achieves at least a minimal response to study treatment at any time during the initial period of 6 cycles can be treated with an additional period of treatment of 6 cycles. Patients are followed 6 months after treatment completion or until a KIR occupancy level \< 30% (i.e if the time required for KIR desaturation was \> 6 months), whichever is longer. #Intervention - DRUG : IPH2101 - 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles - Other Names : - a human monoclonal anti-KIR antibody (1-7F9)

#Eligibility Criteria: Inclusion Criteria: * SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein >= 3 g/dl , AND/OR Bone Marrow plasma cells >= 10 % with no evidence of end-organ damage (CRAB) * (C)Absence of hypercalcemia : Ca < 10.5 mg/dl * (R)Absence of renal failure : creatinine < 2mg/dl (177 μmol/l) or calculated creatinine clearance(according to MDRD) > 50 ml/min * (A)Absence of anemia : Hb > 11 g/dl * (B)Absence of lytic bone lesion on standard skeletal survey (MRI could be used if clinically indicated) * Measurable disease defined as a disease with a serum M protein >= 1 g/dl * No evidence of fatigue, recurrent infections or any clinical suspicion of MM * Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval. * Age > 18 years or < 75 years * ECOG performance status of 0 or 1 * Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study when relevant * Informed consent signed by the patient Exclusion Criteria: * Previous treatment having a proven or potential impact on myelomatous cells proliferation or survival (including IMiDs or proteasome inhibitors, conventional chemotherapies within the last 5 years, steroids within the last month prior to enrolment). Previous bisphosphonates started less than 3 months prior to enrolment. * Use of any investigational agent within the last 3 months * Clinical laboratory values at screening * Platelet < 75 x 10^9 /l * ANC < 1.5 x 10^9 /l * Bilirubin levels >1.5 ULN ; ALT and AST > 3 ULN (grade 1 NCI) * Primary or associated amyloidosis * Abnormal cardiac status with any of the following 1. NYHA stage III or IV congestive heart failure 2. myocardial infarction within the previous 6 months 3. symptomatic cardiac arrhythmia requiring treatment or persisting despite appropriate treatment * Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen * History of or current auto-immune disease * History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma). * Serious concurrent uncontrolled medical disorder * History of allograft or solid organ transplantation * Pregnant or lactating women * Any condition potentially hampering compliance with the study protocol and follow-up schedule Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01222286

{ "NCT_ID" : "NCT02085941", "Brief_Title" : "Image-guided Cryoablation of Head, Neck and Spine Tumors", "Official_title" : "Image-guided Cryoablation of Head, Neck and Spine Tumors", "Conditions" : ["Head and Neck Neoplasms", "Malignant Neoplasm of Vertebral Column"], "Interventions" : ["Device: Biopsy", "Device: Cryoablation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This research study is evaluating a procedure called cryoablation (the removal of diseased tissue using extreme freezing temperatures) as a possible treatment for head, neck and spine tumors. Detailed Description The participant will be assigned to either group 1 for MRI-guided cryoablation or group 2 for PET/CT guided cryoablation. Each participant's placement will be made by a team of radiologists, medical oncologists, surgical oncologists, and radiation oncologists. After the eligibility screening Group 1: The investigators will assess the participant's tumor by Magnetic Resonance Imaging (MRI). This is a safe and standard exam that will show the physician where the participant's tumor is located. MRI scans typically take 60 minutes. The investigator will ask the participant to complete a 'Quality of Life' questionnaire. Following the participant's baseline scan, the physician will schedule the participant's procedure in the Advanced Multimodality Image-Guided Operating (AMIGO) suite. The participant will be placed under general anesthesia for the procedure. A cryoablation needle will be inserted through the skin and into the tumor using MRI guidance. The tip of the cryoablation needle forms an iceball which will be used to ablate the tumor cells. The physician will be able to see the tumor during the procedure through the MRI scan. The procedure will take about 3 hours, and the participant will be spending approximately 2 hours in the post-treatment anesthesia care unit. The participant will spend the subsequent night in the hospital, and will be discharged the next day. The investigators will ask that the participant to return 1 month, 3 months and 6 months post procedure. The participant will be asked to complete the Quality of Life questionnaire at the 1, 3 and 6 month follow up visits. Group 2: The investigators will assess the participant's tumor by a Positron Emission Tomography (PET) scan and Computerized Tomography (CT). These are safe and standard exams that will show the physician where the participant's tumor is located. PET/CT scans typically take 60 minutes. The investigator will ask the participant to complete a 'Quality of Life' questionnaire. Following the participant's baseline scan, the physician will schedule the participant's procedure in the AMIGO suite. The participant will be placed under general anesthesia for the procedure. A cryoablation needle will be inserted through the skin and into the tumor using PET/CT guidance. The tip of the cryoablation needle forms an iceball which will be used to ablate the tumor cells. The physician will be able to see the tumor during the procedure through the PET/CT scan. The procedure will take about 3 hours, and the participant will spend approximately 2 hours in the post-treatment anesthesia care unit. The participant will spend the subsequent night in the hospital, and will be discharged the next day. The investigators ask that the participant return 1 month, 3 months and 6 months post procedure. The participant will be asked to complete the Quality of Life questionnaire at the 1, 3 and 6 month follow up visits. #Intervention - DEVICE : Cryoablation - Cryoablation using 17G Galil cryoprobe - DEVICE : Biopsy - Biopsy using 18G Temno core biopsy needle

#Eligibility Criteria: Inclusion Criteria: * Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Participants must have histologically confirmed malignant tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Participants with malignant locally recurrent and/or metastatic tumors will be eligible for cryoablation. All tumor shapes and sizes will be eligible for ablation. * Participants must have sustained all available treatment options (radiation, chemotherapy, surgery) as verified by the Dana Farber Cancer Institute's Head and Neck Tumor Board. These cases will be reviewed by a team of medical oncologists, radiologists, radiation oncologists, and surgical oncologists. * Participants must have an advanced head, neck or spine malignant tumor that would potentially benefit from a minimally invasive procedure. * Age >= 18 years -- Because no dosing or adverse event data are currently available on the use of cryoablation in participants < 18 years, children are excluded from this study but will be eligible for future pediatric III trials. * Life expectancy of greater than 8 weeks in the opinion of the referring clinician. * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (see Appendix A). * Participants must have normal organ and marrow function as defined below: * Leukocytes >= 3,000/microliter (mcL) * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/microliter (mcL) * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) <= 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal . * Cryoablation can be performed near vessels of the head and neck, and if deemed necessary tumor may be displaced using a saline injection (hydro-displacement). Tumor displacement from nerves may be required and will be performed as deemed appropriate to avoid nerve injury. * The effects of cryoablation on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. * MRI-Guided Cryoablation Criteria-Cohort 1 -- Participants must have a mass that is well-visualized under MRI. Since positron emission tomography-computed tomography (PET-CT) guidance requires the nuclear medicine department to administer a radionuclide material, the default will be to try to use MRI guidance. * PET/CT-Guided Cryoablation Criteria-Cohort 2 -- Patients must have a mass that is well visualized under PET/CT. Tumors that are not clearly seen by MRI but showing on PET/CT will be ablated with PET/CT guidance. Exclusion Criteria: * Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. * Participants with tumors involving the optic chiasm, brain, or spinal cord will not be eligible for participation in this study. Furthermore, tumors that encase any major blood vessel (carotid, jugular, vertebral) will be excluded from the study due to inability to displace these masses. * Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Participants may not be receiving any other study agents. * Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gadolinium contrast agents, if contrast use is anticipated during the procedure. * Participants with a blood glucose level of > 200mg/dl prior to the baseline study, known ischemic disease, and/or impaired renal function (eGFR < 60ml/min) will not be eligible for this study. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because gadolinium is a contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with gadolinium, breastfeeding should be discontinued if the mother is treated with gadolinium. * MRI-Guided Cryoablation Exclusion Criteria-Cohort 1 * -Pregnant women are excluded from this study because gadolinium is a contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with gadolinium, breastfeeding should be discontinued if the mother is treated with gadolinium. * PET/CT-Guided Cryoablation Exclusion Criteria-Cohort 2 * Based on potential risks of fetal loss, teratogenicity, fetal growth retardation and carcinogenesis, PET/CT is contraindicated in the pregnant patient. * Pregnant women are excluded from this study because PET/CT utilizes a radioactive diagnostic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with a radionclide, breastfeeding should be discontinued if the mother is treated. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02085941

{ "NCT_ID" : "NCT02012244", "Brief_Title" : "Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer", "Conditions" : ["Colorectal Surgery"], "Interventions" : ["Drug: fentanyl-based analgesia", "Drug: local anesthetic wound infiltration-based anlagesia"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery #Intervention - DRUG : fentanyl-based analgesia - fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour - DRUG : local anesthetic wound infiltration-based anlagesia - continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour

#Eligibility Criteria: Inclusion Criteria: * ASA class I-III * 20 <= age <= 80 years * elective laparoscopic colorectal surgery for cancer Exclusion Criteria: * drug allergy * significant renal or hepatic impairment * sign of infection Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02012244

{ "NCT_ID" : "NCT03097276", "Brief_Title" : "Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer", "Official_title" : "Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study", "Conditions" : ["Colon and/or Rectal Resection With Anastomosis for Cancer"], "Interventions" : ["Procedure: blood sample", "Radiation: CT scan"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Anastomotic fistula is the most feared complication after surgical resection of colorectal cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate postoperative period, the pain that it induces, the resources required for its management, the need for stomata with a negative impact on patients' quality of life and the prolongation of hospitalization, it also has a now-recognized adverse effect on long-term survival. The early detection of this complication may limit its impact. C-reactive protein (CRP) has proved to be an early, reliable marker of the onset of infectious complications of colorectal surgery. However, the diagnostic procedure to implement in these patients is not at all codified, since this population concerned by systematic CRP assay in the postoperative period is very recent. The procedures to implement in these patients so that they can obtain the maximal benefit of an early diagnosis have not yet been established. An algorithm for the proactive clinical management must be drawn up to be able to confirm or rule out the presence of a fistula as soon as a high level of CRP is detected, and to propose a quick treatment to ensure that patients benefit from this early diagnosis. #Intervention - PROCEDURE : blood sample - blood sample will be collected - RADIATION : CT scan - CT scan

#Eligibility Criteria: Inclusion Criteria: * patients aged 18 and older, * with a CRP level > 140 mg/L at D3 or CRP > 125 mg/L at D4 following colon and/or rectal resection with anastomosis (protected or not by an upstream stoma) * without clinical signs of severe peritonitis (fever, severe sepsis, generalized abdominal contracture) * who have provided written informed consent. Exclusion Criteria: * patients who have undergone intraperitoneal chemotherapy in the context of the surgical treatment for peritoneal carcinomatosis * patients with a diagnosis of another infection that could explain the high CRP level, * patients who underwent eventration repair at the time of the colorectal resection * patients with an obvious indication for revisit surgery * persons without health insurance cover * adults under guardianship * pregnant or beast-feeding women Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03097276

{ "NCT_ID" : "NCT00389389", "Brief_Title" : "Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors", "Official_title" : "A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies", "Conditions" : ["Neoplasms"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis #Intervention - DRUG : AZD4877 - intravenous infusion

#Eligibility Criteria: Inclusion Criteria: * Advanced solid tumors for which standard treatment doesn't exist or is no longer effective. * Relatively good overall health other than your cancer. Exclusion Criteria: * Poor bone marrow function (not producing enough blood cells). * Serious heart conditions. * Poor liver or kidney function. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00389389

{ "NCT_ID" : "NCT00892073", "Brief_Title" : "Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy", "Official_title" : "Combined Diazoxide and Metformin Therapy in Children With Hypothalamic Obesity Secondary to Craniopharyngioma: A Pilot Study", "Conditions" : ["Hypothalamic Obesity"], "Interventions" : ["Drug: Diazoxide", "Drug: Metformin"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary To study the effect of combined diazoxide-metformin therapy on body weight in youth with hypothalamic obesity following treatment for craniopharyngioma. A secondary objective is to evaluate changes in insulin resistance (IR), beta-cell function, features of the metabolic syndrome, muscle metabolism and intramyocellular lipid. Hypothesis: Treatment with diazoxide and metformin will result in weight loss or slowed weight gain and improved metabolic profile, compared to pretreatment levels. Detailed Description 46 children under the age of 22 years have been treated surgically for craniopharyngioma tumor and are currently followed at the Hospital for Sick Children, Toronto. Approximately 50% are obese (BMI ≥ 95th percentile for age and gender assessed from the updated Centre for Disease Control growth charts), all of whom have panhypopituitarism requiring hormone replacement therapy. These children are assessed regularly in Endocrine Clinic and also are invited to attend a comprehensive care clinic for evaluation by an endocrinologist (Principal Investigator), neurosurgical clinical nurse practitioner, dietitian, exercise physiologist, psychologist and social worker to provide multi-disciplinary dietary and exercise consultation and psychological counseling for weight related concerns. This clinic will provide the infrastructure for recruitment and follow-up of study patients. Recruitment of eight subjects for this pilot study will occur over 6 months from patients attending the comprehensive clinic. This number was chosen as it is equivalent to the number chosen in the pilot study of octreotide by Lustig which showed beneficial changes in body mass index with treatment. This study evaluates a novel combination therapy in children with hypothalamic obesity at very high risk for complications. Evaluation of insulin resistance and metabolic changes on therapy will allow a better understanding of how insulin secretion relates to weight gain in this population. Successful therapy in a pilot setting will provide necessary data for a larger randomized trial in individuals with hypothalamic obesity including children with craniopharyngioma and others with damage to the hypothalamus secondary to other tumors, surgery or cranial irradiation. #Intervention - DRUG : Diazoxide - Diazoxide will be initiated at half the dose (100 mg per day) for 2 weeks to allow the insulin sensitizing action of metformin to take effect. Dosage will be increased to 200mg daily, divided twice daily with meals for 6 months. - Other Names : - Proglycem - DRUG : Metformin - Metformin will be initiated at 500 mg twice daily and increased to 1000 mg twice daily over a one week period to minimize gastrointestinal side effects. the 2000mg is to be taken with meals for 6 months. - Other Names : - Novo-metformin

#Eligibility Criteria: Inclusion Criteria: * Craniopharyngioma at least one year following surgery * Evidence of at least one other endocrinopathy of hypothalamic origin * Stable hormone replacement therapy (with one or more of thyroxine hydrocortisone, DDAVP, sex steroids and GH) * Obesity, defined as weight >120% Ideal Body Weight (IBW) or BMI > 27 kg/m2, with normal weight for height before tumour diagnosis and weight gain >2SD above mean for age for 1 year following tumour treatment (41). * Age 9 -22 years * Minimum of 6 months of standard diet and exercise intervention (run-in period). This was chosen to allow a period of prospective measurements to establish individual baseline slope of change in BMI SDS prior to initiation of active treatment with diazoxide and metformin. Exclusion Criteria: * Contraindications for Metformin or Diazoxide use (history or evidence of cardiac, renal, or progressive hepatic disease , diabetes or hypoxic conditions) * Pharmacologic doses of glucocorticoids or use of other medications known to affect glucose metabolism (e.g. beta-blockers, oral hypoglycemics) * Growth hormone (GH) initiation in the preceding 6 months or planned initiation in the next 6 months (to rule out potential confounding effect of GH on weight / body composition and glucose metabolism). * Use of other weight loss medications * Inability of the family and/or patient to comply with study protocol * Non English speaking Sex : ALL Ages : - Minimum Age : 9 Years - Maximum Age : 22 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT00892073

{ "NCT_ID" : "NCT02703064", "Brief_Title" : "Furocyst - Poly Cystic Ovary Syndrome Study", "Official_title" : "To Study the Efficacy and Safety of Furocyst in Poly Cystic Ovary Syndrome Patients (PCOS)", "Conditions" : ["PCOS"], "Interventions" : ["Dietary Supplement: Furocyst"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Poly cystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, affecting approximately 5%-10% of all females worldwide . PCOS is a hormonal disorder that involves multiple organ systems within the body. Its cardinal features are Hyperandrogenism and polycystic ovary (PCO) morphology. Women with PCOS may complains about irregular menstrual periods or heavy menstrual bleeding, infertility, excessive growth of coarse facial and body hair, obesity, oiliness of the skin, seborrhea, and cystic acne. Detailed Description The symptoms of PCOS are anovulation, resulting in irregular menstruation (amenorrhea and oligomenorrhea) ovulation-related infertility, and polycystic ovaries, often associated with obesity, Type 2 diabetes, and high cholesterol levels. The level of serum insulin and insulin resistance are higher in women with PCOS (Hyperinsulinemia).Insulin resistance, defined as the decreased insulin mediated glucose utilization it is more common in women with PCOS up to 50 % in both obese and non obese women . It has also been recognized that some women with this syndrome will have PCO without clinical evidence of androgen excess, but will display evidence of ovarian dysfunction . It is believed to be that, the Hyperinsulinemia of PCOS stimulates the androgens production and increase the activity by decreasing the sex hormone binding globulin (SHBG) thus increasing the free active testosterone level and by the activating the cytochrome P 450 C 17 alpha enzymatic system that controls androgens production. The diagnosis of PCOS is based on Hyperandrogenism and chronic anovulation in the absence of specific pituitary or adrenal disease , and have disrupted ovulatory function with chronic oligomenorrhea (cycle length \> 35 day) or amenorrhea (cycle length \> 12 week) and typical appearance of polycystic ovaries by ultrasound according to the criteria of the Rotterdam consensus meeting 2003 for diagnosis of PCOS. The different diagnostic tests needed to adequately assess for the possibility of PCOS e.g. Pregnancy test, TSH level (for Hyperthyroidism), Prolactin test (for Hyperprolactinemia), Total testosterone (for ovarian tumor) and some tests forevaluating the insulin resistance syndrome in women: Waist circumference (\>88 cm), Triglycerides (\>150 mg/dL), HDL Cholesterol (\<50 mg/dL), Blood pressure (\>130/85) and Fasting glucose (\>110 mg/dL). Fasting glucose- to- insulin ratio and 2 hour oral glucose tolerance test (2h- OGTT 140 - 199 mg/dL) may be better predictor of insulin resistance . The management of the PCOS is symptoms specific e.g. 1. Oral contraceptives, periodic progesterone withdrawal for the control of irregular menstruation. 2. Oral contraceptives, Metformin and anti-androgens (Spironolactone) for the Hirsutism. 3. Clomiphene citrate, Metformin and thiazolidinediones for infertility. A recent study shown that, the combination of Metformin plus Clomiphene citrate should be considered as the First line treatment for infertile women with PCOS . 4. Metformin and lifestyle modification for the insulin resistance and diabetes mellitus. All these management options are only for 'acute' not for 'chronic'. The long-term management approach for the PCOS is needed which will be based on management of most affecting factor insulin resistance. #Intervention - DIETARY_SUPPLEMENT : Furocyst - Furocyst caps BD - Other Names : - Standardized fenugreek extract

#Eligibility Criteria: Inclusion Criteria: * Premenopausal women between 18 <= age <= 45 years and BMI less than 42 * Diagnosed with PCOS by Rottadom Criteria * Adequate hepatic, renal, Cardiac and hematological functions. * Patients willing to Participate and give informed consent in writing as well as in audio-visual form for the study. * Stable weight for last two months (Change of weight<3kg) Exclusion Criteria: * Male * Post menopausal women * Women with hysterectomy * Hyperprolactinemia * Patients with congenital adrenal hyperplasia * Patients suffering from Cushing's syndrome * Acute or chronic Medical illness including Hepatic, Cardiac or renal insufficiency, COPD,Gastrointestinal Disorders * Uncontrolled Hypertensive or known Diabetics on drugs * Use of oral contraceptives or HRT for last three months * Smoking or drug addicts or with psychiatric illness * Patients diagnosed with androgen secreting tumors. * Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age) * Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction) * Pregnant or lactating mothers Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes

NCT02703064

{ "NCT_ID" : "NCT01147822", "Brief_Title" : "Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma", "Official_title" : "A Study to Evaluate Efficacy and Safety of Pazopanib Versus Sunitinib for the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma - A Substudy to VEG108844", "Conditions" : ["Carcinoma, Renal Cell"], "Interventions" : ["Drug: Pazopanib", "Drug: Sunitinib"], "Location_Countries" : ["Taiwan", "Korea, Republic of", "China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is being conducted to provide a direct comparison of the efficacy, safety, and tolerabilityfor pazopanib and sunitinib (SUTENT) in the Asian population. Detailed Description The study is designed to evaluate efficacy and safety of pazopanib versus sunitinib for the treatment of Asian subjects with locally advanced and/or metastatic renal cell carcinoma (RCC) enrolled from selected Far-East Asian countries. The primary objective is to evaluate the primary endpoint progression free survival in the enrolled Asian subjects treated with pazopanib versus those treated with sunitinib. The secondary objectives are to evaluate the following secondary endpoints in each treatment arm: objective response rate, duration of response, time to response, overall survival and safety. Subjects will be randomized in a 1:1 ratio to receive either 800mg pazopanib to be administered once daily orally continuous dosing or 50mg sunitinib to be administered in 6-week cycles: 50mg orally daily for 4 weeks followed by 2 weeks off treatment. Subjects are permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoietin, or bisphosphonates, when appropriate. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdraw consent, or death. #Intervention - DRUG : Pazopanib - 800 mg administered once daily orally continuous dosing - DRUG : Sunitinib - 50 mg sunitinib to be administered in 6-week cycle: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment

#Eligibility Criteria: Inclusion Criteria: * Written informed consent * Diagnosis of renal cell carcinoma with clear-cell component histology. * Received no prior systemic therapy (interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC * Locally advanced or metastatic renal cell carcinoma Measurable disease by CT or MRI * Karnofsky performance scale status of >=70 * Age >=18 years * A female is eligible to enter and participate in this study if she is of: non-childbearing or agrees to use adequate contraception. * Adequate organ system function * Total serum calcium concentration <12.0mg/dL * Left ventricular ejection fraction >= lower limit of institutional normal Exclusion Criteria: * Pregnant or lactating female (unless agrees to refrain from nursing throughout the treatment period and for 14 days following the last dose of study)-History of another malignancy (unless have been disease-free for 3 years) * History or clinical evidence of central nervous system (CNS) metastases (unless have previously-treated CNS metastases and meet all 3 of the following criteria are: are asymptomatic, have had no evidence of active CNS metastases for >=6 months prior to enrolment, and have no requirement for steroids or enzyme-inducing anticonvulsants) * Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment * Presence of uncontrolled infection * Prolongation of corrected QT interval (QTc) > 480 milliseconds * History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association * History of cerebrovascular accident including transient ischemic attack within the past 12 months * History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless had recent DVT and have been treated with therapeutic anti-coagulating agents for at least 6 weeks) * Poorly controlled hypertension (defined as systolic blood pressure of >=150mmHg or diastolic blood pressure of >=90mmHg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry * Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. * Evidence of active bleeding or bleeding susceptibility * Spitting/coughing up blood within 6 weeks of first dose of study drug * Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels * Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study * Use any prohibited medications within 14 days of the first dose of study medication * Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug * Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc), or are mTOR inhibitors (eg. temsirolimus, everolimus, etc). * Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy) * Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01147822

{ "NCT_ID" : "NCT02063022", "Brief_Title" : "Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma", "Official_title" : "Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma.", "Conditions" : ["Ewing's Sarcoma"], "Interventions" : ["Drug: Standard treatment (as per protocol ISG SSG III)", "Drug: Intensified chemotherapy"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Controlled, randomized phase III study, with the intent of optimizing the treatment of not metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs intensive treatment. Both arms will receive an induction treatment followed by surgery (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on the basis of the response to the induction treatment (good or poor) Detailed Description Eligible patients with non metastatic Ewing's Sarcoma will be randomized into 2 different arms: standard treatment arm A (based on the ISG/SSG III protocol) or into the experimental arm B(chemotherapy with dose intensification and shorter length of treatment). Both arm will receive an induction treatment with higher dose intensity of doxorubicin and ifosfamide in Arm B. After the induction treatment all the patient will undergo to local treatment (surgery and/or radiotherapy)that will be followed by a maintenance therapy. The maintenance therapy will be different for both arms and, within each arm, on the basis of the response (histologically evaluated) of the pre-local treatment therapy. Maintenance for Arm A: Poor responders will undergo to stem cells apheresis and their reinfusion after treatment with high doses of Busulfan and Melphalan 25 weeks. Good responders will receive a 6 drugs maintenance treatment for 37 weeks (as per standard ISG/SSG III protocol) Maintenance for Arm B: Poor responders will undergo to stem cells apheresis and their reinfusion after an intensified treatment with high doses of Busulfan and Melphalan (25 weeks). Good responders will receive a maintenance treatment for 25 weeks The primary aim of the study is to assess the Event Free Survival (EFS) that is expected to be similar in both arms The secondary objectives are: To assess if the induction treatment in Arm B is able to increase the percentage of good responders compared to those who receive standard treatment. To assess the toxicity and the Quality of Life related to the chemotherapy treatment #Intervention - DRUG : Standard treatment (as per protocol ISG SSG III) - Induction treatment with: 4 cycle of Vincristine (9mg/,2), Dactinomycin (6mg/m2), Doxorubicin (160mg/m2), Cyclophosphamide (2.4g/m2), Ifosfamide (18g/M2) and Etoposide (450mg/m2) given every 3 weeks Maintenance treatment for poor responder (25 weeks): Vincristine (12mg/m2), Dactinomycin (1.5mg/m2), Doxorubicin (320mg/m2), Ifosfamide (27g/m2), Cyclophosphamide (8.8g/m2), Etoposide (1.5g/m2) and peripheral Cells Steam Transplant after Busulfan and Melphalan treatment Maintenance treatment (37 week) for good responder: Vincristine (18mg/m2), Dactinomycin (6mg/m2), Doxorubicin (400mg/m2), Ifosfamide (72g/m2), Cyclosphosphamide(6g/m2), Etoposide (1.8 g/m2) - Other Names : - Vincristine, Dactinomycin, Doxorubicin, Ifosfamide, Cyclophosphamide, Etoposide, Busulfan, Melphalan - DRUG : Intensified chemotherapy - * Induction treatment with: 4 cycle of Vincristine (10.5 mg/m2), Doxorubicin (320 mg/m2) and Ifosfamide (36 mg/m2) given every 3 weeks * Maintenance treatment for poor responder (25 weeks): Vincristine (12mg/m2), Doxorubicin (400mg/m2), Ifosfamide (63g/m2), Cyclophosphamide (4g/m2), Etoposide (1.5g/m2) and Cells Steam Transplant after Busulfan and Melphalan treatment * Maintenance treatment (25 week) for good responder: Vincristine (12mg/m2), Doxorubicin (400mg/m2), Ifosfamide (72g/m2), Etoposide (1.8g/m2) - Other Names : - Vincristine,, Doxorubicin, Ifosfamide, Cyclophosphamide, Etoposide, Busulfan, Melphalan

#Eligibility Criteria: Inclusion Criteria * Ewing Sarcoma or PNET diagnosis centrally confirmed * Age <= 40 years * Absence of evident metastasis or lung met < 0.5 cm Presence of skip metastasis in the bone compartment of the primary tumor is to be considered as local disease and not metastatic. * Adeguate bone marrow, hepatic and renal function * Left Ventricular Ejection Fraction > 50% * No primary Ewing Sarcoma treatments (both chemotherapy and/or radiotherapy) * Voluntarily signed an informed consent form * Radiological and histological documentation available for central review. Exclusion Criteria * Presence of lung or extra-pulmonary lesions * Bone Marrow involvement * In case of chest disease: presence of plural effusion * Elapsed time between histological diagnosis and chemotherapy start, more than 4 weeks * Any medical contraindication to the use of the study drugs * Any psychological or social conditions that can compromise the protocol compliance and/or follow-up * Previous malignancies (excluded in situ cervix carcinoma) Sex : ALL Ages : - Maximum Age : 40 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT02063022

{ "NCT_ID" : "NCT02339558", "Brief_Title" : "Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer", "Official_title" : "Multicenter Phase II Study of Nivolumab in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma", "Conditions" : ["Nasopharyngeal Nonkeratinizing Carcinoma", "Recurrent Nasopharynx Carcinoma", "Stage III Nasopharyngeal Carcinoma AJCC v7", "Stage IV Nasopharyngeal Carcinoma AJCC v7", "Stage IVA Nasopharyngeal Carcinoma AJCC v7", "Stage IVB Nasopharyngeal Carcinoma AJCC v7", "Stage IVC Nasopharyngeal Carcinoma AJCC v7"], "Interventions" : ["Other: Laboratory Biomarker Analysis", "Biological: Nivolumab"], "Location_Countries" : ["Singapore", "China", "United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells. Detailed Description PRIMARY OBJECTIVES: I. Objective tumor response to nivolumab in patients with previously treated recurrent and/or metastatic nasopharyngeal carcinoma (NPC) based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1. SECONDARY OBJECTIVES: I. Tumor response to nivolumab based on immune-related response criteria (IRC). II. Duration of response. III. Progression-free survival and overall survival. IV. Safety and tolerability. TERTIARY OBJECTIVES: I. To investigate the effect of nivolumab on tumor burden by analyzing the clearance of plasma Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) during the first 4-6 weeks of treatment. II. To investigate the association between treatment outcome and immunological markers: a) Intratumoral expression of programmed cell death 1 (PD-1) and programmed cell death-ligand (PD-L1) in archived NPC tissues (mandatory); b) Serum absolute lymphocyte count at baseline and post-treatment (mandatory); and c) Plasma cytokine levels at baseline and serially during the first 8 weeks of treatment; d) Expression of PD-1 in cluster of differentiation (CD)8+ T cells in tumor infiltrating lymphocytes (TIL) at baseline (optional). III. To investigate functional magnetic resonance imaging (MRI) sequences as an early predictor of response to nivolumab (optional only at Chinese University of Hong Kong \[CUHK\]). OUTLINE: Patients receive nivolumab intravenously (IV) over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years. #Intervention - OTHER : Laboratory Biomarker Analysis - Correlative studies - BIOLOGICAL : Nivolumab - Given IV - Other Names : - BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

#Eligibility Criteria: Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at locoregional and/or distant sites; NOTE: patients with local recurrence at the bony skull-base as the only site of index disease are excluded; patients with locoregional recurrence without distant metastases must have undergone radical radiotherapy previously * Measurable disease according to the RECIST criteria (version 1.1), for the evaluation of measurable disease * Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery * Archived or fresh tumor sample available; willingness to donate blood and tissue for mandatory correlative research studies * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Absolute neutrophil count >= 1.5 x 10^9/L * Platelet count >= 100 x 10^9/L * Hemoglobin >= 8.0 g/dL * Serum alanine aminotransferase ([ALT]; serum glutamate-pyruvate transferase [SGPT]), or serum aspartate aminotransferase [AST] where available at the center) < 2.5 x upper limit of normal (ULN), OR < 5 x ULN in the presence of liver metastases * Serum total bilirubin < 2 x ULN (except patients with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) * Serum creatinine < 1.5 x ULN Exclusion Criteria: * Any of the following: * Chemotherapy =< 4 weeks prior to registration * Radiotherapy =< 4 weeks prior to registration * Nitrosoureas =< 6 weeks prior to registration or * Mitomycin C =< 6 weeks prior to registration * Those who have not recovered from adverse events (to grade =< 1 in severity) due to agents administered more than 4 weeks earlier; prior palliative radiotherapy to bone metastases =< 2 weeks prior to registration (i.e. prior palliative radiotherapy to bone metastases is allowed if it is performed > 2 weeks prior to registration) * Prior investigational agents =< 4 weeks prior to registration * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Known brain metastases or leptomeningeal metastases; NOTE: symptomatic, and/or if they require immunosuppressive doses of corticosteroids (e.g. > 10 mg/day prednisone or equivalents) for at least 2 weeks prior to study drug administration; patients with treated brain metastases who are deemed clinically stable and without radiological progression on positron emission tomography (PET), MRI or computed tomography (CT) scan performed =< 8 weeks of study entry, are not excluded; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab * History of severe hypersensitivity reaction to any monoclonal antibody * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception NOTE: breastfeeding should be discontinued if the mother is treated with nivolumab; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; they must adhere to contraception for a period of 31 weeks after the last dose of nivolumab * For patients with unknown human immunodeficiency virus (HIV) status at the time of enrollment, HIV serology must be tested during screening; patients who are tested positive for HIV could be included if there is an adequate cluster of differentiation 4 (CD4) count (> 350/ul) on a stable regimen of highly active anti-retroviral therapy (HAART) with no detectable or minimal viral burden, and no active infections * For patients with unknown hepatitis B virus surface antigen (HbsAg) status, must be tested during study screening; patients who are tested positive test for HBsAg are excluded if they have inadequately controlled hepatitis B and/or Child-Pugh Class B or C cirrhosis; however, patients with adequately controlled hepatitis are not excluded from the study if they satisfy all of the following criteria: (i) must be receiving a nucleoside analog anti-viral drug for 3 or more months; and (ii) have a serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) level of less than 100 IU/ml via polymerase chain reaction quantification assays prior to enrollment * For patients with unknown hepatitis C virus ribonucleic acid (HCV antibody) status, must be tested during study screening; patients who are tested positive for HCV antibody are excluded from the study if they have inadequately controlled hepatitis C and/or Child-Pugh Class B or C cirrhosis; patients with adequately controlled hepatitis are not excluded from the study as defined by having undetectable level of serum HCV antibody level prior to enrollment; patients who are currently on interferon or other anti-HCV therapy will be excluded from study * Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; NOTE: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible * Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) * Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted * Evidence of active or acute (i.e. current, or recent within 4 weeks prior to registration) diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation; patients with abdominal carcinomatosis, a history of non-recent intra-abdominal abscess, or a history of non-recent GI obstruction should be evaluated for the potential need for additional treatment before coming on study Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02339558

{ "NCT_ID" : "NCT00535795", "Brief_Title" : "Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA", "Official_title" : "A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA", "Conditions" : ["Nasopharyngeal Carcinoma"], "Interventions" : ["Radiation: Radiation Therapy"], "Location_Countries" : ["Saudi Arabia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA Detailed Description It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma. #Intervention - RADIATION : Radiation Therapy - Radiation Therapy

#Eligibility Criteria: Inclusion Criteria: * Patients with nasopharyngeal Carcinoma Exclusion Criteria: * Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: No

NCT00535795

{ "NCT_ID" : "NCT01734928", "Brief_Title" : "Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma", "Official_title" : "A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma", "Conditions" : ["Multiple Myeloma"], "Interventions" : ["Drug: Bortezomib", "Drug: Dexamethasone", "Drug: Pomalidomide"], "Location_Countries" : ["Ireland", "Sweden", "Portugal", "Germany", "France", "Canada", "Poland", "Turkey", "United Kingdom", "Puerto Rico", "Greece", "Austria", "Russian Federation", "Finland", "Denmark", "Israel", "Netherlands", "Norway", "Italy", "United States", "Spain", "Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone. #Intervention - DRUG : Pomalidomide - Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle. - Other Names : - Oral Pomalidomide, CC-4047 - DRUG : Bortezomib - Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression. - Other Names : - Velcade - DRUG : Dexamethasone - Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\>75 years old\] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

#Eligibility Criteria: Inclusion Criteria: * Must be >= 18 years at the time of signing informed consent. * Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis. * Must have had at least 1 but no greater than 3 prior anti-myeloma regimens. * Must have documented disease progression during or after their last anti-myeloma therapy. * All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles. Exclusion Criteria: * Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule. * Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization. * Non-secretory multiple myeloma. * Subjects with severe renal impairment requiring dialysis. * Previous therapy with pomalidomide. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01734928

{ "NCT_ID" : "NCT01171729", "Brief_Title" : "Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer", "Official_title" : "A Phase I/IIa Study of Autologous Cell-based Vaccine Therapy With CreaVax-PC in Hormone-Refractory Metastatic Prostate Cancer Patients With PSA Relapse to Evaluate the Safety and Efficacy", "Conditions" : ["Prostatic Cancer"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open label, Phase I/IIa trial of immunotherapy with CreaVax-PC as treatment in men with hormone-Refractory Metastatic Prostate Cancer. Detailed Description CreaVax-PC consisted of antigen (PSA, PAP and KLH) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens. If patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (CreaVax-PC). In detail, patients will receive CreaVax-PC injection at intervals of 3 weeks, maximum 6 times during 21 weeks. PSA increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. We also evaluate time to progression, overall survival and immune response. #Intervention - BIOLOGICAL : Autologous dendritic cell - Autologous dendritic cells pulsed with prostate cancer antigen and KLH - Other Names : - CreaVax-PC

#Eligibility Criteria: Inclusion Criteria: * 1) Histological confirmed prostatic carcinoma patient * 2) Hormone non-respondence ex1) Although treatment PSA >= 5ng/ml ex2) PSA level were measured two times ex3) Prior one year radiology were processed * 3) Just 18 years over * 4) Has a score <=1 on the ECOG Performance Scale * 5) Expected survival life time >= 6month * 6) Adequate bone marrow function hemoglobin >= 10.0g/dL , leukocyte count >= 4,000/mm3 thrombocyte >= 100,000/mm3 * 7) Adequate blood coagulation function PT(INR) < 1.5, aPTT< 1.5 x control * 8) Adequate kidney function Normal blood upper level Creatinine <= 1.5 times * 9) Adequate liver function Normal blood upper level AST/ALT <= 1.5 times * 10) Autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity * 11) Person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy * 12) Patient who voluntarily participated clinical trial and confirmed a written consent Exclusion Criteria: * 1) Having other malignancy or previous history of malignancy * 2) Brain metastases patient * 3) Having autoimmune disease or its history * 4) Pyrexia, rigor, leukocytosis infectious disease * 5) HBsAg, anti-HCV, HIV positive patient * 6) Myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension * 7) Severe and active medical disease * 8) Mental history disease or epilepsy * 9) Patients participated other clinical trial within 4 weeks * 10) Patients impossible to participate this trial by investigator's decision * 11) Patients who received immunosuppressant such as steroid, cyclosporin A, azathioprine within 6 weeks Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01171729

{ "NCT_ID" : "NCT02900326", "Brief_Title" : "Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer", "Official_title" : "Effect of a Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help to Improve Exercise Capacity and Quality of Life in Breast Cancer", "Conditions" : ["Breast Cancer"], "Interventions" : ["Other: Cerebral IRMf", "Other: Both interventions together", "Other: Vo2max measurements", "Genetic: Telomerase activity on a blood sample", "Other: Quality of life (questionnaires)", "Other: Endurance exercise training", "Other: Mindfulness-based-stress-reduction"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer. #Intervention - OTHER : Endurance exercise training - In each group, there will be a comparison of aerobic capacity, quality of life (with questionnaires), functional cerebral measurements (fRMI), and telomerase activity between before and after the 8 weeks program - OTHER : Mindfulness-based-stress-reduction - OTHER : Both interventions together - OTHER : Vo2max measurements - GENETIC : Telomerase activity on a blood sample - OTHER : Quality of life (questionnaires) - OTHER : Cerebral IRMf

#Eligibility Criteria: Inclusion Criteria: * Breast cancer * Having completed the chemotherapy period * Undergoing radiotherapy and/or hormono therapy Exclusion Criteria: * Regular physical activity higher than 4 hours per week. * Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training ) Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02900326

{ "NCT_ID" : "NCT00138177", "Brief_Title" : "Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors", "Official_title" : "A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX) in Patients With Colorectal Cancer and Other Solid Tumors", "Conditions" : ["Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage III Colon Cancer", "Stage III Rectal Cancer", "Stage IV Colon Cancer", "Stage IV Rectal Cancer", "Unspecified Adult Solid Tumor, Protocol Specific"], "Interventions" : ["Drug: oxaliplatin", "Drug: fluorouracil", "Drug: leucovorin calcium", "Drug: vorinostat"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial is studying the side effects and best dose of suberoylanilide hydroxamic acid when given together with fluorouracil, leucovorin, and oxaliplatin in treating patients with progressive metastatic or unresectable colorectal cancer or solid tumor. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Detailed Description PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of suberoylanilide hydroxamic acid when administered with fluorouracil, leucovorin calcium, and oxaliplatin in patients with progressive metastatic or unresectable colorectal cancer or other solid tumors. SECONDARY OBJECTIVES: I. Determine the toxicity of this regimen in these patients. II. Determine the pharmacokinetics of oxaliplatin, fluorouracil, and suberoylanilide hydroxamic acid in these patients. OUTLINE: This is a dose-escalation study of suberoylanilide hydroxamic acid (SAHA). Patients receive oral SAHA once or twice daily on days 1-3. Patients also receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 4 followed by fluorouracil IV over 46 hours on days 4-5. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD. After completion of study treatment, patients are followed for 4 weeks. #Intervention - DRUG : oxaliplatin - Given IV - Other Names : - 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP - DRUG : leucovorin calcium - Given IV - Other Names : - CF, CFR, LV - DRUG : vorinostat - Given orally - Other Names : - L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza - DRUG : fluorouracil - Given IV - Other Names : - 5-fluorouracil, 5-Fluracil, 5-FU

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed colorectal cancer * Metastatic or unresectable disease OR diagnosis of solid tumor * No known brain metastases * ECOG 0 <= age <= 1 OR Karnofsky 70 <= age <= 100% * Life expectancy > 12 weeks * Absolute neutrophil count >= 1,500/mm^3 * WBC >= 3,000/mm^3 * Platelet count >= 100,000/mm^3 * Bilirubin normal * AST and ALT <= 3 times upper limit of normal * Creatinine normal OR creatinine clearance >= 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No ongoing or active infection * No neuropathy > grade 1 * No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No psychiatric illness or social situation that would preclude study compliance * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * Prior bevacizumab and/or cetuximab allowed * No concurrent routine or prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * More than 4 weeks since prior radiotherapy * Recovered from prior therapy * At least 2 weeks since prior valproic acid * No concurrent combination anti-retroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer therapy Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00138177

{ "NCT_ID" : "NCT02719574", "Brief_Title" : "Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation", "Official_title" : "A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation", "Conditions" : ["Acute Myeloid Leukemia", "Acute Myelogenous Leukemia", "Myelodysplastic Syndrome"], "Interventions" : ["Drug: Cytarabine", "Drug: FT-2102 (olutasidenib)", "Drug: Azacitidine"], "Location_Countries" : ["Korea, Republic of", "United Kingdom", "Australia", "Italy", "Germany", "United States", "France", "Spain", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states. #Intervention - DRUG : FT-2102 (olutasidenib) - FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level - DRUG : Azacitidine - azacitidine will be administered per site's standard of care - Other Names : - Vidaza - DRUG : Cytarabine - low-dose cytarabine will be administered per site's standard of care

#Eligibility Criteria: Inclusion Criteria: * Pathologically proven acute myeloid leukemia (AML) (except acute promyelocytic leukemia [APL] with the t(15;17) translocation) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy. * Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site * Good performance status * Good kidney and liver function Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy * Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02719574

{ "NCT_ID" : "NCT00656812", "Brief_Title" : "Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue (MALT) Lymphoma", "Official_title" : "Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)", "Conditions" : ["Lymphoma of Mucosa-Associated Lymphoid Tissue"], "Interventions" : ["Drug: 2-CdA", "Drug: Rituximab"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue (MALT). Detailed Description Currently, there is no chemotherapeutic standard treatment for patients with MALT lymphoma either presenting with disseminated disease or with relapsing/refractory disease following local treatment (including radiation) or eradication of HP. Various compounds have been tested, including alkylating agents such as cyclophosphamide or chlorambucil, the nucleoside analog cladribine (2CdA), as well as combination regimens including CHOP or MCP (mitoxantrone, chlorambucil, prednisone), but only limited data exists from prospective trials. Thus, trials to evaluate the potential of new compounds in patients with advanced MALT lymphoma are not only justified, but seem warranted. While systemic approaches were until recently thought to be justified only in patients with disseminated disease, emerging data suggest that also patients with localized disease potentially amenable to radiation may benefit from systemic treatment. This has been demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in a randomized fashion, where application of chemotherapy resulted in a significantly longer time to relapse as opposed to surgery or radiation without impairing overall survival. Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy in MALT lymphoma have been published to date. This study will therefore evaluate the efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of the mucose associated lymphoid tissue. #Intervention - DRUG : Rituximab - 375 mg/m2 on day 1 of a 21-day treatment cycle - Other Names : - MabThera - DRUG : 2-CdA - 0.1 mg/kg s.c. on days 1 - 4 of a 21-day treatment cycle - Other Names : - Litak

#Eligibility Criteria: Inclusion Criteria: * Histologically proven diagnosis of MALT lymphoma of any localization * Disseminated disease upon diagnosis in case of gastric lymphoma or first or greater relapse after local therapy (including gastrectomy or surgery), prior chemotherapy or HP-eradication. In addition, also patients with localized gastric lymphoma judged refractory to HP-eradication by a minimum follow-up of 12 months after successful HP-eradication can be included in the study. * Measurable disease * ECOG performance status of 0,1 or 2 * Age at least 18 years * Life expectancy of at least 3 months * Adequate cardiac, renal and liver function tests (LVEF > 50%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range (ULN), alkaline phosphatase < 2.5 x ULN, serum bilirubin < 2.0 mg/dl) * Patient must be willing and able to comply with the protocol for the entire study duration * Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period * Patient's written informed consent Exclusion Criteria: * Lymphoma histology other than MALT lymphoma or MALT lymphoma transforming to diffuse large cell lymphoma ('high grade lymphoma') * Use of any investigational agent 30 days prior to inclusion * History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years * Major surgery, other than diagnostic surgery, within the last 4 weeks * Evidence of CNS involvement * A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs * Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months * Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophile count (segmented + bands) <1.0 x 109/L * Patients with active opportunistic infections * Pregnant or breast feeding women Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00656812

{ "NCT_ID" : "NCT03930992", "Brief_Title" : "Efficacy of Zoledronic Acid + Colaren vs Zoledronic Acid + Conventional Treatment for Osteoporosis in HIV+ and HIV- Men", "Official_title" : "Efficacy of 4 mg Zoledronic Acid Plus Colaren vs 4mg Zoledronic Acid + Conventional Treatment for Secondary Osteoporosis in HIV Positive and Negative Men", "Conditions" : ["Secondary Osteoporosis"], "Interventions" : ["Drug: Colaren in HIV negative", "Drug: standard treatment in HIV negative", "Drug: standard treatment in HIV positive", "Drug: Colaren in HIV positive"], "Location_Countries" : ["Mexico"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Clinical trial to assess the effectiveness of the supplement Colaren® associated with zoledronic acid 4mg/annually in the treatment of osteoporosis secondary, compared to standard treatment plus zoledronic acid 4mg/annually. The standard treatment will include 1gr of calcium/day and vitamin D supplement. In both cases, vitamin D levels will be determinated, which should remain at more than 30 ng/mL. Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism, bone formation and bone resorption will be assessment. The all parameters above will be assessed basally (before the start of treatment), after starting the treatment, an assessment will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile, at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned above will be measured. Detailed Description This study is a clinical trial to assess the effectiveness of the supplement Colaren® associated with annually zoledronic acid 4mg, in the treatment of osteoporosis secondary or not to HIV infection, compared to standard treatment plus zoledronic acid 4mg/annually. The standard treatment will include 1gr of calcium/day and vitamin D supplement. In both cases, vitamin D levels will be evaluated, which should remain at more than 30 ng/mL. Including men with osteoporosis secondary to HIV and men with osteoporosis secondary to any other cause (HIV negative). Vitamin D levels, bone densitometry and markers of metabolism, bone formation and bone resorption will be assessment. The all parameters above will be assessed basally (before the start of treatment), after starting the treatment, an assessment will be made at 12 weeks where vitamin D levels and bone markers will be measured. Meanwhile, at week 24 assess only vitamin D levels; and finally, at week 52 all parameters mentioned above will be measured. #Intervention - DRUG : Colaren in HIV positive - 1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium). - Other Names : - plus Zoledronic Acid 4 mg - DRUG : standard treatment in HIV positive - 2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate) - Other Names : - plus Zoledronic Acid 4 mg - DRUG : Colaren in HIV negative - 3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium). - Other Names : - plus Zoledronic Acid 4 mg - DRUG : standard treatment in HIV negative - 4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate) - Other Names : - plus Zoledronic Acid 4 mg

#Eligibility Criteria: Inclusion Criteria: * Adult males 18 <= age <= 65 old. * HIV diagnosis (HIV positive group) or negative HIV serology (HIV negative group). * Patients receiving HAART and sustained virologic control for at least two years. * Patients meeting diagnostic criteria for osteoporosis. * Subjects willing to participate voluntarily in this study and give a written consent. * Estimated glomerular filtration rate >60 mL/min (Using CKD-EPI formula). Exclusion Criteria: * Use of calcium, vitamin D or any other drug with bone activity during the last 90 days previous to the study. * Use of herbs or herb products during the last 90 days previous to the study. * Positive test for HCV or HBV. * Patients who cannot be submitted to complete examination for variable analysis. * Glomerular filtration rate <60 mL/minute. * Active liver disease. * Non-compliance to treatment (less than 90%). * Patients who are not willing to continue participating. Non-inclusion criteria: * Female patients. * Use of immunosuppressive o immunomodulatory treatment 90 days previous to selection. * Use of prohibited drugs for the study like: antiestrogens, corticosteroids (doses greater than 7.5mg of prednisone/day) 90 days previous to selection. * Use of hormone therapy. * Patients with history or actual use of chemotherapy. * Patients deprived of freedom or imprisoned patients with mental illnesses. * Participant is part of another clinical trial or nutritional program. * Hypogonadism diagnosis with not having received hormonal replacement previous to the study. * Primary osteoporosis diagnosis. Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03930992

{ "NCT_ID" : "NCT02216656", "Brief_Title" : "Phase 2 Study of KHK7580", "Official_title" : "A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis", "Conditions" : ["Secondary Hyperparathyroidism"], "Interventions" : ["Drug: KHK7580 low dose", "Drug: KHK7580 high dose", "Drug: KRN1493", "Drug: KHK7580 middle dose", "Drug: Placebo"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis. #Intervention - DRUG : Placebo - Oral administration - DRUG : KHK7580 low dose - Oral administration - DRUG : KHK7580 middle dose - Oral administration - DRUG : KHK7580 high dose - Oral administration - DRUG : KRN1493 - Oral administration - Other Names : - cinacalcet

#Eligibility Criteria: Inclusion Criteria: * Subjects who have voluntarily consented to participate in this study * Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening * Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening Exclusion Criteria: * Subjects with primary hyperparathyroidism * Subjects who have received cinacalcet hydrochloride within 2 weeks before screening * Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening. * Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening. * Subjects with uncontrolled hypertension and/or diabetes * Subjects with severe heart disease. * Subjects with severe hepatic dysfunction. * Subjects who have received any other investigational drug within 12 weeks before screening * Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 74 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02216656

{ "NCT_ID" : "NCT00134355", "Brief_Title" : "Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer", "Official_title" : "Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: PTK787"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels. Detailed Description This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter. Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA (Prostate-specific Antigen) has doubled from pretreatment baseline. #Intervention - DRUG : PTK787

#Eligibility Criteria: Inclusion Criteria: * Histologic or cytologic diagnosis of prostate cancer * No evidence of metastatic disease * PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal * Patients must maintain castrate levels of testosterone (<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy. * ECOG (Eastern Cooperative Oncology Group) performance status of 0 <= age <= 2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death) * No prior anti-VEGF therapy is allowed * No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy * Age greater than or equal to 18 years * Life expectancy greater than 6 months * Normal organ and marrow function obtained within 14 days prior to registration * Must use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: * Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration. * Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy. * Uncontrolled incurrent illness * Patients with a 'currently active' second malignancy are not eligible. * Major surgery less than or equal to 4 weeks prior to randomization * Prior chemotherapy less than or equal to 3 weeks prior to registration * Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration * Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration * Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration. * Patients must not be on nonsteroidal antiandrogen blockade. * Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis. Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00134355

{ "NCT_ID" : "NCT01634685", "Brief_Title" : "A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma", "Official_title" : "A Phase I Study of the Phosphatidylserine-Targeting Antibody Bavituximab in Combination With Capecitabine and Radiation Therapy for the Treatment of Stage II and III Rectal Adenocarcinoma", "Conditions" : ["Rectal Adenocarcinoma"], "Interventions" : ["Drug: Capecitabine", "Drug: Bavituximab", "Radiation: Radiation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a phase I study incorporating bavituximab into the care of patients with rectal adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no reference therapy as we are trying to identify the MTD of bavituximab in this combination. Detailed Description The investigational drug in this protocol is bavituximab, which will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself. If the other therapies are terminated after week 4 the bavituximab treatment may be continued per protocol. A chemotherapy agent, capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2. Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction. Surgery will follow the last bavituximab administration by 4-8 weeks (6-10 weeks following completion of radiation therapy. #Intervention - RADIATION : Radiation - Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction. - DRUG : Bavituximab - Bavituximab will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself. - Other Names : - Phosphatidylserine-Targeting Antibody - DRUG : Capecitabine - capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2. - Other Names : - Xeloda

#Eligibility Criteria: Inclusion Criteria: * Biopsy-proven invasive adenocarcinoma of the rectum, stage T3 <= age <= 4 and/or node-positive (AJCC stage II or III). For the purpose of this study, a tumor is located in the 'rectum' when its distal edge is located within 12cm of the anal verge. The distal edge of the tumor can be delineated by digital examination or endoscopic examination, including colonoscopy, although rigid proctoscopy is preferred. * Age > 18 years. * Performance status of 0 or 1 on the ECOG scale is required (See Appendix 1). * Adequate organ and marrow function as defined below: * leukocytes >= 3,000/mcL * absolute neutrophil count >= 1,500/mcL * platelets >= 100,000/mcl * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper limit of normal * creatinine <1.5 X institutional upper limits of normal * aPTT <=1.5 X institutional upper limits of normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; * or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia). * Bleeding 1. Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding (excluding bleeding from rectal tumor), and hemoptysis within the 12 months before screening. If clinically significant bleeding has occurred within 12 months of screening but the cause has been identified and adequately treated (e.g., cystitis, ulcer), then this exclusion criterion does not apply. 2. Minor biopsy-related bleeding lasting < 24 hours and resolved at least 1 week before Study Day 1 is allowed. * Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) within 6 months of screening. * Ongoing therapy with oral or parenteral anticoagulants; low-dose anticoagulation to maintain patency of lines is allowed. * Concurrent estrogens, anti-estrogens or progesterone compounds. * Any prior radiation for rectal cancer. * Symptomatic or clinically active brain metastases. * Major surgery within 4 weeks of Study Day 1. * Pregnant or nursing women. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of blood clotting abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements. * Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of screening. * Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis. * Known hypersensitivity to any components of the treatments. * History of malignancy other than non-melanoma skin cancers within 5 years prior to study enrollment. * Subjects receiving other investigational agents thirty days prior to study treatment or during treatment. * History of inflammatory bowel disease Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01634685

{ "NCT_ID" : "NCT00261027", "Brief_Title" : "Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer", "Official_title" : "A Pilot, Phase II, Single Center, Non-comparative, Open-label Study of Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer", "Conditions" : ["Ovarian Cancer"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This project is a pilot, phase II, open-label, single-center, non-comparative clinical study evaluating the antitumor efficacy and tolerability of exemestane in treating adult post-menopausal women with recurrent or refractory, stage II-IV, epithelial ovarian cancer. To evaluate the efficacy and tolerability of exemestane in this population, patients will be enrolled at a single site, namely the Ottawa Regional Cancer Center. Patients selected according to the criteria outlined will receive exemestane (25 mg/day given orally once daily) until disease progression or until study withdrawal. These patients will be treated on an out-patient basis. There is no specific wash-out time required for patients who have previously received either cis or carboplatinum; however, this previous therapy must stop upon patient inclusion into this trial. In 1st stage if less than 2/15 patients achieve a response then study will be terminated. In 2nd stage if greater than 7/28 patients achieve a response then no further investigation of the drug is warranted.Treatment (including drug dosages) A commercial supply of exemestane (Aromasin) will be provided. The medication will be administered by the patient at home (25 mg taken orally once daily until disease progression) The medication should be taken each day after a meal at the same time of the day. There are no patient diaries and no need for the patient to record the time of administration. Detailed Description This project is a pilot, phase II, open-label, single-center, non-comparative clinical study evaluating the antitumor efficacy and tolerability of exemestane in treating adult post-menopausal women with recurrent or refractory, stage II-IV, epithelial ovarian cancer. To evaluate the efficacy and tolerability of exemestane in this population, patients will be enrolled at a single site, namely the Ottawa Regional Cancer Center. Patients selected according to the criteria outlined will receive exemestane (25 mg/day given orally once daily) until disease progression or until study withdrawal. These patients will be treated on an out-patient basis. There is no specific wash-out time required for patients who have previously received either cis or carboplatinum; however, this previous therapy must stop upon patient inclusion into this trial. In 1st stage if less than 2/15 patients achieve a response then study will be terminated. In 2nd stage if greater than 7/28 patients achieve a response then no further investigation of the drug is warranted. Treatment (including drug dosages) A commercial supply of exemestane (Aromasin) will be provided. The medication will be administered by the patient at home (25 mg taken orally once daily until disease progression) The medication should be taken each day after a meal at the same time of the day. There are no patient diaries and no need for the patient to record the time of administration. #Intervention - DRUG : Exemestane

#Eligibility Criteria: Inclusion Criteria: * · Patients aged >= 18 years with a documented diagnosis of metastatic, stage II-IV, epithelial ovarian cancer and a histological/cytological confirmation of disease.· Patients must be oophorectomized or be post-menopausal (i.e. no menses within the last 12 months).· Patients should have objective evidence of measurable disease according to the modified RECIST guidelines. If no measurable disease is present, there must be a CA 125 level of ³ 30 U/mL in combination with non-measurable disease and/or ascites.· Patients may be designated:· First line - patients who have either refused or did not qualify for initial therapy with standard cis- or carboplatin + paclitaxel.· Refractory - progression while on chemotherapy, or relapse within 12 months of final chemotherapy (with a maximum of 2 lines of chemotherapy treatment)· Recurrent - relapse beyond 12 months of final chemotherapy (with a maximum of 2 lines of chemotherapy treatment)· In patients having received radiation therapy, at least 4 weeks must have passed subsequent to the cessation of the radiation therapy, prior to the baseline assessment in this study.· Patients with ECOG performance status of 0, 1 or 2 and a life expectancy of &gt; 3 months.· Patients must have adequate haematological (WBC ³ 4000/mL, neutrophils ³ 2000/mL, platelets ³ 100,00/mL), hepatic (total bilirubin £ 1.5 x upper limit normal (ULN), AST/ALT £ 3 x ULN)) and renal (serum creatinine &lt; 1.5 X ULN) organ functions.· Patients must give written informed consent signed prior to registration. Exclusion Criteria: * Known hypersensitivity to exemestane· Participation in another clinical study within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy.· Patients with rapidly progressive disease for which hormonal therapy may not be indicated.· Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin. Patients with other malignancies must be disease free for at least 5 years.· Patients with metastatic disease of the central nervous system, eg. Paraneoplastic cerebellar degeneration, metastatic medulloblastoma, intramedullary spinal cord involvement, etc.· Patients having received prior hormonal therapy for ovarian cancer including tamoxifen and aromatase inhibitors.· Patients with any other concurrent disease, which in the opinion of the Investigator, would make the patient inappropriate for entry into this study.· Patients who are not accessible for treatment and follow-up in scheduled hours at the participating center. Sex : FEMALE Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00261027

{ "NCT_ID" : "NCT00863746", "Brief_Title" : "A 3rd/4th Line Placebo-controlled Trial of Sorafenib in Patients With Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC).", "Official_title" : "A Phase III, Multi-center, Placebo-Controlled Trial of Sorafenib (BAY43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non-Small Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens for Advanced Disease", "Conditions" : ["Carcinoma", "Non-Small-Cell Lung"], "Interventions" : ["Drug: Sorafenib (Nexavar, BAY43-9006)", "Drug: Placebo"], "Location_Countries" : ["Peru", "Korea, Republic of", "Thailand", "Sweden", "Germany", "France", "Canada", "Philippines", "Poland", "Turkey", "United Kingdom", "Singapore", "Greece", "Austria", "Bulgaria", "Chile", "Hong Kong", "Russian Federation", "South Africa", "Belgium", "Hungary", "China", "Pakistan", "India", "Israel", "Taiwan", "Brazil", "Netherlands", "Argentina", "Italy", "United States", "Indonesia", "Spain", "Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone. Detailed Description Acronyms used in Adverse Events section: Disseminated intravascular coagulation (DIC), International normalized ratio (INR), Atrioventricular (AV), Gastrointestinal (GI), Not otherwise specified (NOS), Common Terminology Criteria for Adverse Events (CTCAE), Absolute neutrophil count (ANC), Central nervous system (CNS), Acute respiratory distress syndrome (ARDS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST). #Intervention - DRUG : Sorafenib (Nexavar, BAY43-9006) - Sorafenib 400 mg twice daily (BID) - DRUG : Placebo - Placebo - 2 tablets twice daily (BID)

#Eligibility Criteria: Inclusion Criteria: * Ability to understand and willingness to sign a written Informed Consent * Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically * Patients must have measurable or non-measurable disease * At least two but not more than three prior standard treatment regimens for NSCLC * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Male or female subjects >= 18 years (>=20 for Japan) at the time of Informed Consent * Life expectancy of at least 12 weeks * Ability to swallow oral medication * Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug: * Haemoglobin > 9.0 g/dl * Absolute neutrophil count (ANC) >1,500/mm3 * Platelet count >= 100,000/µl * Total bilirubin <=1.5 x the upper limit of normal * Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (<= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (<= 5 x upper limit of normal in patients with liver metastases) * Alkaline phosphatase < 4 x upper limit of normal (<= 5 x upper limit of normal in patients with liver metastases) * Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal * Serum creatinine < 1.5 x upper limit of normal * Calculated creatinine clearance of >= 50 mL/min Exclusion Criteria: * NSCLC patients with predominantly squamous cell carcinoma histology Excluded medical conditions: * History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE [National Cancer Institute-Common Terminology Criteria for Adverse Events] vers. 3.0) * Uncontrolled hypertension despite two anti-hypertensive medications * History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C * History of organ allograft * Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0) * Patients with seizure disorder requiring medication * Patients with evidence or history of bleeding diathesis or coagulopathy * Patients undergoing renal dialysis * Pulmonary hemorrhage/ bleeding event >= CTCAE grade 2 within four weeks prior to the first dose of the study drug * Any other hemorrhage/ bleeding event >= CTCAE grade 3 within four weeks prior to the first dose of the study drug * Thrombotic or embolic venous or arterial events such as cerebrovascular accident * Pregnant or breast-feeding women. * Any condition which could affect the absorption or pharmacokinetics of the study drug * Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents [VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00863746

{ "NCT_ID" : "NCT00428233", "Brief_Title" : "Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation", "Official_title" : "Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation", "Conditions" : ["Chronic Lymphocytic Leukemia"], "Interventions" : ["Procedure: Leukemia cell harvest"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants' own CLL cells may form part of a vaccine treatment for their leukemia. Detailed Description * It is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. First, we may not be able to make enough vaccine from the collected cells. Second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. Third, an appropriate vaccine trial may not be available in the future. * In order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node. * The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected. #Intervention - PROCEDURE : Leukemia cell harvest - Leukemia cells will be harvested either by: Blood draw, leukapheresis, bone marrow aspiration or surgery to remove the lymph node

#Eligibility Criteria: Inclusion Criteria: * Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as > 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis > 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm. * ECOG performance status 0 <= age <= 2 * 18 years or older Exclusion Criteria: * Uncontrolled infection * Leukemia with active CNS involvement Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00428233

{ "NCT_ID" : "NCT02463799", "Brief_Title" : "Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC", "Official_title" : "A Phase 2 Study of Sipuleucel-T With or Without Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Drug: Radium-223", "Biological: Sipuleucel-T"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This clinical trial studies the effect of radium-223 when added to sipuleucel-T for treating castrate-resistant prostate cancer that has spread to the bone. Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response against prostate cancer. It has been suggested that the immune response may be strengthened by radiation therapy. Therefore this study is testing whether radium-223 added to sipuleucel-T increases the immune response and anti-tumor effect against prostate cancer. Detailed Description This is a randomized study designed to assess the antigen-specific immune response of sipuleucel-T with or without radium-223. Eligible subjects will be registered and randomly assigned in a 1:1 ratio to receive sipuleucel-T and radium-223 or sipuleucel-T alone. Subjects in both arms (sipuleucel-T and radium) will undergo a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an IV infusion of sipuleucel-T. This process will occur a total of 3 times at approximately 2-week intervals. Subjects in Arm 1 will receive a total of 6 infusions of radium-223 at IV dose of 50 kBq/kg at 4-week interval. All participants are allowed to receive the best supportive care which includes secondary hormonal manipulation as required. No chemotherapy, external-beam radiation, or other radionuclides are allowed while on active treatment but are permitted after completion of active treatment. Glucocorticoid-containing treatments should be minimized to less than the equivalent dose of prednisone 10mg daily if feasible for the 3 months following sipuleucel-T therapy. All patients continue medical or surgical castration during treatment. #Intervention - DRUG : Radium-223 - 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223 - Other Names : - Xofigo, BAY88-8223 - BIOLOGICAL : Sipuleucel-T - 3 infusions of sipuleucel-T alone - Other Names : - Provenge

#Eligibility Criteria: Inclusion Criteria: * Written informed consent provided prior to initiation of study procedures * Age >= 18 years * Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma * Bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening * Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (<= 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in PSA OR new lesions on bone scan: * PSA progression will be defined as 2 rising PSA values compared to a reference value, measured at least 7 days apart and the second value is >= 2 ng/mL [1]. It must be documented within 2 months of screening. * Appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression. It must be documented within 4 months of screening * Serum PSA >= 2.0 ng/mL * Screening ECOG perf status <= 1 * Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed) * Prior abiraterone and enzalutamide are permitted, but not required * Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month * Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges <= 28 days prior to registration: * Absolute neutrophil count (ANC) >= 1.5 x109/L * Platelet count >= 100 x109/L * Hemoglobin >= 10.0 g/dL * Total bilirubin level <= 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN * Creatinine <= 1.5 x ULN * Albumin > 25 g/L Exclusion Criteria: * The presence of known lung or liver metastases greater than 1.0 cm in the long axis diameter * The presence of lymphadenopathy greater than 3 cm in the short-axis diameter * The presence of known brain metastases * Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase * Previous treatment with chemotherapy for mCRPC (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration * Intention to receive chemotherapy within 6 months after enrollment in protocol therapy * History of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration * Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks * Prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers) * Use of prednisone or equivalent systemic corticosteroid within 2 weeks of treatment. Use of inhaled, intranasal, intra-articular, and topical steroids is allowed. Oral or IV steroids to prevent or treat IV contrast reactions are allowed * Use of opioid analgesics for cancer-related pain * Use of experimental drug within 4 weeks of treatment * Uncontrolled medical conditions including diabetes, heart failure, COPD, ulcerative colitis, or Crohn's disease * Uncontrolled fecal incontinence * Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02463799

{ "NCT_ID" : "NCT04628988", "Brief_Title" : "A Study of CC-90011 and Comparators in Participants With Prostate Cancer", "Official_title" : "A Phase 1, Open-label, Functional Imaging Study to Assess Whether CC-90011 Reverses the Castration Resistance Due to Lineage Switch in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Failed Enzalutamide as Last Prior Therapy, Followed by a Dose Finding Study of CC-90011 Combined With Abiraterone and Prednisone", "Conditions" : ["Prostatic Neoplasms"], "Interventions" : ["Drug: CC-90011", "Drug: Prednisone", "Drug: Abiraterone"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC -90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to lineage switch, in participants with mCRPC that have failed enzalutamide as last prior therapy. This study aims to assess whether CC-90011 can induce AR expression and, consequently, re-sensitize tumors to anti-hormonal therapy. #Intervention - DRUG : CC-90011 - Capsule - DRUG : Abiraterone - Tablet - Other Names : - Zytiga - DRUG : Prednisone - Tablet - Other Names : - Deltasone

#Eligibility Criteria: Inclusion Criteria: * Participant is a male >= 18 years the time of signing the informed consent form (ICF). * Histologically confirmed adenocarcinoma of the prostate. * Surgically or medically castrated, with testosterone levels of < 50 ng/dL (<2.0 nM). If the participant is being treated with luteinizing hormone-releasing hormone (LHRH) agonists/antagonists (participant who have not undergone orchiectomy) this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study. Participants must have failed prior therapy with enzalutamide or apalutamide * Has completed at least 12 weeks of prior continuous therapy with enzalutamide or apalutamide . * Has been without enzalutamide, or apalutamide treatment for >30 days prior to initiation of study treatment. * Documented prostate cancer progression as assessed by the investigator with one of the following: * Prostate-specific antigen (PSA) progression defined by a minimum of 3 rising PSA levels with an interval of >=1 week between each determination. The PSA value at screening must be >=1 µg/L (1 ng/mL) if PSA is the only indication of progression; participants on systemic glucorticoids for control of symptoms must have documented PSA progression by PCWG3 criteria while on systemic glucocorticoids prior to commencing Cycle 1 Day 1 treatment. * Radiographic progression of soft tissue disease by RECIST 1.1 or bone metastasis with 2 or more documented new bone lesions on a bone scan with or without PSA progression. * Participants must have FDHT lesion >2 cm lesion that has an SUVmax of 2.9 or less in bone, or 2.4 or less in soft tissue, or two or more smaller lesions that meet those criteria. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening. * Participants must have the following laboratory values: * Absolute neutrophil count (ANC) >= 1.5 x 109/L without growth factor support for 7 days (14 days if participant received pegfilgastrim) * Hemoglobin (Hgb) >= 9 g/dL (>= 90 g/L or > 5.59 mmol/L) * Platelet count (plt) >= 100 x 109/L * Serum potassium concentration within normal range, or correctable with supplements * Serum AST/SGOT and ALT/SGPT <= 3.0 x Upper Limit of Normal (ULN) or <= 5.0 x ULN if liver metastases are present * Serum total bilirubin <= 1.5 x ULN (<= 2 x ULN in case of documentened Gilbert). * Participants must have serum albumin >= 3.0 g/dL * Serum creatinine <= 1.5 x ULN, or measured glomerular filtration rate (GFR) >= 60 mL/min/1.73m2 using an exogenous filtration marker such as iohexol, inulin, 51Cr EDTA or 125I iothalamate. In cases where the serum creatinine is < 1,5xULN, there is no need to calculate GFR. * PT (or INR) and activated partial thromboplastin time (APTT) 1. within normal range (Part A) 2. <=1.5 ULN Exclusion Criteria: * Participant has received anti-cancer therapy (either approved or investigational) < 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. - < 42 days for prior nitrosureas or mitomycin C * Toxicities resulting from prior systemic cancer therapies must have resolved to <= NCI CTCAE Grade 1 prior to starting CC-90011 treatment (with exception of Grade 2 peripheral neuropathy and alopecia). * Previous anaphylactic reaction to either FDHT or FDG. * Participant has undergone major surgery <= 4 weeks or minor surgery <= 2 weeks prior to Cycle 1 Day 1 or who have not recovered from surgery. * Participant has completed any radiation treatment < 4 weeks prior to Cycle 1 Day 1 or < 2 weeks for palliative bone radiotherapy (single fraction). Participants with > 25% of myelopoietic bone marrow radiation are not allowed to be enrolled on this study. * Participant has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) >= NCI CTCAE Grade 2, despite medical management), or any other significant GI disorder that could affect the absorption of CC-90011. * Participant with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages. * Participant with any hemorrhage/bleeding event > CTCAE Grade 2 or haemoptysis > 1 teaspoon within 4 weeks prior to the first dose * Symptomatic and untreated or unstable central nervous system (CNS) metastases or clinically significant spinal cord compression. * Participant recently treated with whole brain radiation or stereotactic radiosurgery for CNS metastases must have completed therapy at least 4 weeks prior to Cycle 1, Day 1 and have a follow-up brain computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating either stable or improving metastases 4 or more weeks after completion of radiotherapy (the latter to be obtained as part of the Screening Assessments, refer to Section 6.1) * Participant must be asymptomatic and off steroids or on stable dose of steroids for at least 4 weeks (?10 mg/day prednisone equivalent) * Participant has known symptomatic acute or chronic pancreatitis. * Participant with severe hepatic impairment (Child-Pugh Class C). * Medical castration with LHRH analogue is not permitted at any time during treatment with abiraterone and prednisone if not started at least 4 weeks prior to Cycle 2 Day 1. * Participant has impaired cardiac function or clinically significant cardiac diseases, including any of the following considered to be clinically significant by the subject's physician: * LVEF < 45% as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO) * Complete left bundle branch or bifascicular block * Congenital long QT syndrome * Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation. * QTcF >= 450 msec on Screening ECG (mean of triplicate recordings) * Unstable angina pectoris or myocardial infarction <= 6 months prior to starting CC-90011 * Participant has other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ? 160/95 mm Hg). * Participants who are known to be human immunodeficiency virus (HIV) positive with an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection within the last year, a detectable viral load, or a current CD4 count < 350 cells/uL. * Participant has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA > 500 IU/mL (2500 copies/mL), or active hepatitis C. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C participants can be enrolled. * Participant with ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonist). Low dose low molecular weight heparin for catheter maintenance and for short-term prophylaxis for participants with prior pulmonary embolism (PE) and deep vein thrombosis (DVT) are permitted under careful consideration by the Investigator. * Participant has a history of concurrent second cancers requiring active, ongoing systemic treatment. * Participant has any significant medical condition (eg, active or uncontrolled infection or renal disease), the presence of laboratory abnormalities, or psychiatric illness that would prevent the participant from participating (or compromise compliance) in the study or would place the participant at unacceptable risk if he/she were to participate in the study. * Participants with poor bone marrow reserve as assessed by Investigator such as in the following conditions of: * Having received extensive bone radiotherapy * Having experienced several episodes of bone marrow aplasia in previous treatments * Requiring regular hematopoietic support (blood transfusion, erythropoietin, GCSF) * Participant has any condition that confounds the ability to interpret data from the study. * Participant does not tolerate the study drug components. * Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1). * Acute symptoms must have resolved and based on investigator assessment in consultation with the Study Sponsor Physician, there are no sequelae that would place the subject at a higher risk of receiving study treatment * Previous SARS-CoV-2 vaccine within 7 days of C1D1. For vaccines requiring more than one dose, the full series (e.g. both doses of a two-dose series) should be completed prior to C1D1 when feasible and when a delay in C1D1 would not put the study subject at risk. Sex : MALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04628988

{ "NCT_ID" : "NCT02323295", "Brief_Title" : "Effect of High Doses of Radiation on Bone Structure and Metabolism", "Official_title" : "Pilot Study of the Effect of High Doses of Radiation on Bone Metabolism and Structure in Patients Treated With Adjuvant Radiotherapy and Surgery for Sacral Tumors", "Conditions" : ["Malignant Bone Tumors"], "Interventions" : ["Procedure: Malignant Tumor Surgery", "Radiation: Radiation (Non-surgical Arm)", "Radiation: Radiation (Surgical Arm)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In this research study, the investigators are looking to determine changes in blood markers, bone density, and bone structure following radiation and to better understand the reason for these changes. Detailed Description Participants in the Surgical Arm of the study will be treated according to the schedule outlined in protocol for a combined treatment with surgery and adjuvant high dose radiotherapy. Patients in the non surgical arm of the the study will be treated according to the protocol being treated with radiotherapy alone. #Intervention - RADIATION : Radiation (Surgical Arm) - For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) - RADIATION : Radiation (Non-surgical Arm) - Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) - PROCEDURE : Malignant Tumor Surgery - Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor

#Eligibility Criteria: Inclusion Criteria: * All laboratory tests that are a part of the eligibility criteria must be completed within 14 days prior to the date of registration. Diagnostic tests that are a part of the eligibility criteria must be performed within 30 days of the date of registration. Participants must meet the following criteria on screening examination to be eligible to participate in the study: * Study participants must have histologically confirmed primary malignant bone tumor in the sacrum for which surgery and radiation or radiation alone are planned. * Age >= 18 years. In children under the age of 8, tetracycline derivatives have been reported to stain tooth enamel yellow color. These considerations lead us to exclude young persons under the age of 18 from the study. * Participants must have normal organ and marrow function as defined below: * Total bilirubin within normal institutional limits * Aspartaataminotransferase (AST) (SGOT)/ Alanine-aminotransferase (ALT) (SGPT) < 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal limit * The effects of tetracyclines and radiation used in computer tomography on the developing human fetus are known to be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Participants must be able to read and understand English language and have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. * Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study * History of allergic reactions attributed to compounds of similar chemical or biologic composition to tetracyclines. * Pregnant or nursing * Uncontrolled inter current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02323295

{ "NCT_ID" : "NCT00517595", "Brief_Title" : "Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC", "Official_title" : "A Phase II Study of Pemetrexed and Gemcitabine Plus Bevacizumab as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer", "Conditions" : ["Non-Small Cell Lung Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden. #Intervention - DRUG : Pemetrexed and Gemcitabine plus Bevacizumab - Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m\^2 and gemcitabine 1500 mg/m\^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks. - Other Names : - Pemetrexed/Alimta, Gemcitabine/Gemzar, Bevacizumab/Avastin

#Eligibility Criteria: Inclusion Criteria: * Patient provides voluntary written informed consent before performance of any study-related procedure not part of normal medical care. * Patient >= 65 years with ECOG of 0 to 1 * Patient must have histologically/cytologically confirmed Stage IIIB/IV NSCLC. * Patient has measurable disease defined as at least 1 lesion that can be accurately measured in at least 1 dimension (by CT or MRI) & used to assess response as defined by RECIST criteria. Tumors within a previously irradiated field will be designated nontarget lesions. * Patient has not received radiotherapy within 2 weeks(4 weeks required for brain metastases radiotherapy)of initial chemotherapy dosing for this study, and all acute toxicities due to prior radiotherapy have resolved prior to initial chemotherapy dosing. * Patient has a negative serum pregnancy test or has undergone hysterectomy at time of enrollment. * Greater than 12 weeks life expectancy. * Patient has recovered from any recent surgery for at least 30 days & is free of active infection requiring antibiotics. * Patient must be willing/able to discontinue use of NSAIDS prior to study drug dosing. * Patient must be able to take folic acid, Vitamin B12, & dexamethasone per protocol. * Patient must exhibit no greater than Grade 1 peripheral neuropathy. Exclusion Criteria: * Prior systemic or other concurrent chemo for metastatic NSCLC(Prior Tarceva is not allowed).Prior adjuvant chemo acceptable as long as > 12 months since completion and no prior pemetrexed, gemcitabine or bevacizumab. * Lung carcinoma of squamous cell histology(mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable.Patients with extrathoracic-only squamous cell NSCLC are eligible.Patients with only peripheral lung lesions (of any NSCLC histology) will also be eligible(a peripheral lesion is defined as a lesion in which the epicenter of the tumor is <= 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is > 2 cm from the trachea, main, and lobar bronchi). * Hemoptysis within 1 month prior to study enrollment * Ongoing treatment with full-dose warfarin or its equivalent i.e., unfractionated and/or low molecular weight heparin.(Low dose warfarin 1 mg given for prophylaxis is allowed). * Hypersensitivity to any component of Alimta, gemcitabine &/or bevacizumab, &/or cannot tolerate folic acid, corticosteroids or Vitamin B12 supplements. * Currently/have recently taken long-acting NSAID (Ibuprofen <= 400 mg QID acceptable) or aspirin (>325mg/day) within 5 days of initial pemetrexed administration. * Clinically significant pericardial/pleural effusion or ascites unless able to be drained before study entry. * Presence of third space fluid which cannot be controlled by drainage. * Core biopsy/other minor surgical procedure(excluding placement of a vascular access device)within 7 days prior to study enrollment. * Active infection or fever >= 38.5°C within 3 days of first scheduled day of protocol treatment. * Serious, non-healing wound, ulcer, or untreated bone fracture. * NYHA Grade II or greater CHF * Inadequately controlled hypertension (defined as systolic blood pressure > 150 &/or diastolic blood pressure > 100mmHg on antihypertensive meds) * Any prior history of hypertensive crisis or hypertensive encephalopathy. * History of MI, CVA, TIA, or unstable angina within 6 months of study enrollment. * Significant vascular disease (aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis.) * Symptomatic peripheral vascular disease * Known bleeding diathesis or coagulopathy * Presence of CNS(central nervous system) except for treated brain metastases. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging(MRI or CT)during the screening period.Anticonvulsants(stable dose)are allowed.Treatment for brain metastases may include whole brain radiotherapy(WBRT),radiosurgery(RS;Gamma Knife,LINAC,or equivalent)or a combination as deemed appropriate by the treating physician.Radiotherapy must be completed at least 4 weeks prior to study enrollment and all acute radiotherapy toxicities resolved.Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded. * A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study. * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment. * History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate specific antigen of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry. * Have received radiotherapy to more than 25% of their bone marrow. * Receiving concurrent investigational therapy or has received investigational therapy within 30 days of the first scheduled day of protocol treatment * Pregnant/lactating. * Any other medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate/participate in the study, or interfere with interpretation of the results. * History of allogeneic transplant. * Known HIV infection or Hepatitis B or C. Sex : ALL Ages : - Minimum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No

NCT00517595

{ "NCT_ID" : "NCT04819373", "Brief_Title" : "BDB001-201: A Clinical Study of BDB001 in Patients With PD-(L)1 Refractory Solid Tumors", "Official_title" : "A Phase 2, Open-label, Multi-Arm Trial to Evaluate the Efficacy and Safety of BDB001 in the Treatment of Subjects With Advanced Solid Tumors That Have Progressed on Anti-PD-1 or Anti-PD-L1 mAb Treatment", "Conditions" : ["Tumor, Solid"], "Interventions" : ["Drug: BDB001"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary BDB001-201 is a multi-center, open-label, Phase II clinical trial to evaluate the efficacy and safety of BDB001 in the treatment of subjects with advanced solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment. Detailed Description BDB001-201 is a multi-center, open-label, multi-arm Phase II study evaluating an experimental immunotherapy drug called BDB001. BDB001 is a Toll-like receptor 7/8 (TLR7/8) agonist delivered intravenously to systemically activate the innate and adaptive immunity in the treatment of various tumors. The objectives of this study are to evaluate the efficacy, safety and tolerability of intravenous BDB001 administered as monotherapy in subjects with histologically-confirmed unresectable or metastatic solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment either as monotherapy or in combination with other therapies. The following tumor types may be included in the trial: Non-Small Cell Lung Cancer (NSCLC); Cutaneous Squamous Cell Carcinoma (cSCC); Head and Neck Squamous Cell Carcinoma (HNSCC); Melanoma; Merkel Cell Carcinoma (MCC); Renal Cell Carcinoma (RCC); Urothelial Carcinoma; other types of solid tumors at the discretion of the Sponsor. Each tumor type will be analyzed independently #Intervention - DRUG : BDB001 - BDB001 is an immunotherapy agent.

#Eligibility Criteria: Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: * Histologically or cytologically confirmed: Cutaneous SCC, Head and Neck SCC, Melanoma, Merkel Cell Carcinoma, NSCLC, Renal Cell Carcinoma, or Urothelial Carcinoma. Other tumor types will be allowed at Sponsor's discretion. * Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination. * Eastern Cooperative Oncology Group (ECOG) score of 0 - 2 * At least 1 lesion with measurable disease at baseline * Availability of a lesion for biopsy and consent to allow pre-treatment tumor biopsy. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: * Greater than 4 lines of prior DNA-damaging chemotherapies. * Uncontrolled CNS metastases. * Active autoimmune disease. Other protocol defined inclusion/exclusion criteria could apply Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04819373

{ "NCT_ID" : "NCT02264886", "Brief_Title" : "Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies", "Official_title" : "Pilot Study of Online, Adaptive MRI-Guided SBRT for Unresectable Primary or Oligometastatic Central Thorax and Abdominal Malignancies", "Conditions" : ["Central Thorax Cancer", "Liver Cancer", "Non-Liver Abdominal Cancer"], "Interventions" : ["Radiation: MRI-guided stereotactive body radiation therapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this research study is evaluate whether it's feasible to give radiation therapy using an MRI-guided adaptive technique. MRI-guided adaptive radiation therapy involves the adjustment or re-planning of treatment day by day while the participant is receiving treatment. The adaptive technique has previously been used in a different fashion to adjust the treatment plan after the fact, but using MRI scanning to re-plan treatment while the participant is still on the table is a new way of using the adaptive technique. This may allow doctors to use more radiation to treat the tumor while better protecting normal tissues. A special radiation treatment machine incorporates both an MRI scanner and radiation treatment devices so that the planning and treatment can be done using the same machine. Detailed Description In this trial, the feasibility of delivering online, adaptive MRI-guided stereotactic body radiation therapy for oligometastatic disease using a novel, integrated Co-60-MRI machine will be evaluated. To best assess this technology, we will focus on three specific oligometastatic disease sites that have historically highlighted the limitations of SBRT. Specifically, we will enroll patients with oligometastatic disease of the central thorax, liver, and non-liver abdomen to receive adaptive, MRI-guided SBRT with MRI simulation and MRI treatment gating. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care, but allow adaptation based on daily anatomic changes. The prescription dose will be determined based on above hard normal tissue constraints, and capped at 15 Gy per fraction. Although our long-term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by short-term goals of demonstrating feasibility of an on-table adaptive approach, which has never previously been reported. #Intervention - RADIATION : MRI-guided stereotactive body radiation therapy - Other Names : - SBRT

#Eligibility Criteria: Inclusion Criteria: * Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven primary disease histology of solid tumor categorization with the exception of small cell cancers. * Must be deemed medically fit for SBRT to the liver or lung by the treating physician. * At least 18 years. * Karnofsky performance status > 60 (see Appendix A) * Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred). * Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Primary disease of hematologic origin, lymphoma, or small cell cancer. * Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT. * Widespread progressive disease, i.e., more than 3 sites of progressive disease (more than 3 sites of disease are permitted provided there are no more than 3 sites of progressive disease). * Currently receiving any other investigational agents. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry. * Medical contraindication to undergoing MR imaging. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02264886

{ "NCT_ID" : "NCT02303990", "Brief_Title" : "RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers", "Official_title" : "RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers", "Conditions" : ["Metastatic Cancers"], "Interventions" : ["Drug: Pembrolizumab", "Radiation: Radiotherapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who have have progressed after at least one regimen of systemic therapy (breast, pancreas, and other). #Intervention - DRUG : Pembrolizumab - RADIATION : Radiotherapy

#Eligibility Criteria: Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Be 18 years on day of signing informed consent. * Histologically confirmed diagnosis of cancer as per the cohort specifications * Stage IV cancer by AJCC staging criteria (except for pancreatic cancer cohort) * Locally advanced or metastatic pancreatic cancer for the pancreatic cancer cohort * Progression of disease while on anti-PD-1 or anti-PD-L1 therapy for melanoma and NSCLC patients. For this group, patients must met the following criteria: 1. Received at least 2 doses of an anti-PD1 or anti-PD-L1 therapy 2. Had progressive disease documented radiologically by RECIST v1.1 criteria. * Progression or refractory disease to at least one regimen of therapy for metastatic disease in the breast and pancreatic cancer cohorts * Presence of an index lesion > 1 cm amenable to hypofractionated radiotherapy * Patients who have metastatic cancer must have at least one lesion that is outside the radiation field that measures greater than one cm that can be followed by RECIST 1.1. This lesion, if it is close to the radiated lesion, must receive no more than 10% of the dose prescribed to the target lesion. * Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Ability to tolerate hypofractionated radiation therapy (e.g. lie flat and hold position) * Demonstrate adequate organ function , all screening labs should be performed within 14 days of treatment initiation. * Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) >=1,500 /mcL Platelets >=100,000 / mcL Hemoglobin >=9 g/dL or >=5.6 mmol/L Renal Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) * 1.5 X upper limit of normal (ULN) OR >=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic Serum total bilirubin * 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) * 2.5 X ULN OR * 5 X ULN for subjects with liver metastases Creatinine clearance should be calculated per institutional standard * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria * The subject must be excluded from participating in the trial if the subject: * Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Systemic steroids administered specifically as a premedication for chemotherapy infusion or radiotherapy are allowed. * Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent. * Note: Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study. * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * A history of prior radiotherapy that precludes delivery of hypofractionated radiotherapy * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. * Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study. * Has evidence of interstitial lung disease or active, non-infectious pneumonitis. * Has an active infection requiring systemic therapy. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). * Has received a live vaccine within 30 days prior to the first dose of trial treatment. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02303990

{ "NCT_ID" : "NCT04075097", "Brief_Title" : "Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain", "Official_title" : "Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain", "Conditions" : ["Breast Cancer", "Chemotherapy-induced Peripheral Neuropathy", "Neuropathic Pain"], "Interventions" : ["Behavioral: Aerobic exercise", "Behavioral: Iyengar yoga"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates the acute effect of aerobic exercise and yoga on pain, plasma levels of endocannabinoids, and mood (i.e., mood disturbance and anxiety). Participants will complete three separate sessions on different days. The first session is a familiarization session in which participants complete questionnaires and are familiarized with the experimental protocols. During the second and third sessions, outcomes are measured before and after the participants complete either 44 minutes of moderate aerobic exercise (i.e., walking on a treadmill) or 44 minutes of yoga. #Intervention - BEHAVIORAL : Aerobic exercise - 1 session - BEHAVIORAL : Iyengar yoga - 1 session

#Eligibility Criteria: Inclusion Criteria: * A diagnosis of breast cancer (stage 0-III), * no evidence of active disease (i.e., recurrence, bone metastases, etc), * presence of painful polyneuropathy, with onset coinciding or developing after receiving chemotherapy agents that in the opinion of the research team is likely to have caused such symptoms, * at least six months since last active cancer treatment, with no further planned treatment (Note. active treatment is defined as surgery, chemotherapy, or radiation), * the participant agrees to use the safety stop feature on the treadmill if needed, * at least 18 years, * and their physicians has provided consent for them to participate in yoga and aerobic exercise sessions. Exclusion Criteria: * Undergoing current chemotherapy or radiation treatment for cancer, * taking anticoagulant therapy, * uncontrolled medical conditions (i.e., uncontrolled hypertension, heart disease, stage 4 liver disease, end-stage renal disease, end-stage pulmonary disease, etc), * stroke or myocardial infarction in the past 6 months, * being pregnant or planning to become pregnant, * severe mobility constraints (e.g., confined to a wheelchair), * having a history of light headedness or fainting during blood draws or physical activity. Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04075097

{ "NCT_ID" : "NCT03507088", "Brief_Title" : "Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer", "Official_title" : "Fluorine-18 Fluoroestradiol Positron Emission Tomography-computed Tomography: an in Vivo Biomarker Predicting Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer?", "Conditions" : ["Metastatic Breast Cancer"], "Interventions" : ["Drug: Fluoroestradiol (18F)"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this study we will determine the utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen positive metastatic breast cancer Detailed Description More than 70% of patients with metastatic breast cancer present with hormone receptor positive disease and for whom hormonal therapy is the preferred treatment approach. First-line treatment recommendations for women with hormone receptor positive locally advanced or metastatic disease includes a generation aromatase inhibitors or tamoxifen. Fulvestrant, a 17β-estradiol analog, is an antiestrogen that suppresses estrogen signaling by binding to ER and inducing oestrogen receptor degradation and has estrogen antagonistic activity but no estrogen agonistic effect. Fulvestrant has been shown to have superiority over other endocrine therapy in a series of randomized controlled trials. The whole-body imaging of the availability of ER using FES-PET may prove valuable to evaluate the effects of fulvestrant on the ER non-invasively in individual patients. This potentially allows early prediction of therapy efficacy to fulvestrant in women with estrogen positive metastatic breast cancer. In this pilot-study we will evaluate 35 patients who received fulvestrant as treatment for metastatic breast cancer. All patients will undergo FES-PET/CT at baseline and FES-PET after 28 days. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results. #Intervention - DRUG : Fluoroestradiol (18F) - A FES-PET/(CT) will be performed twice during protocol execution. Patients will be injected with approximately 222 MBq 18F-FES each time.

#Eligibility Criteria: Inclusion Criteria: * Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence. * No previous fulvestrant treatment * ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of aromatase inhibitors is allowed. * Age > 18 * ECOG 0 <= age <= 2 * Life expectancy > 6 months * Informed consent obtained * Able to comply with the protocol Exclusion Criteria: * Presence of life-threatening visceral metastases * Evidence of central nervous system metastases * > 3 lines of endocrine therapy for metastatic disease * Isolated liver metastasis (high FES uptake by normal liver) Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT03507088

{ "NCT_ID" : "NCT04621500", "Brief_Title" : "Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans", "Official_title" : "Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans", "Conditions" : ["Prostate Cancer", "Vitamin D Deficiency", "Stress Reaction"], "Interventions" : ["Diagnostic Test: Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation", "Drug: cholecalciferol", "Procedure: Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq", "Procedure: Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "BASIC_SCIENCE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Veterans between the ages of 50-75, who are having a prostate biopsy, will be recruited for their permission to collect an extra biopsy core for RNA-sequencing. If the participants' treatment decision is Active Surveillance, they will be enrolled into the intervention phase of the study. They will receive supplementation with Vitamin D3 (4,000 IU) daily with repeat (surveillance) prostate biopsy one year later. At that time an extra prostate sample core will be collected for RNA-sequencing to determine changes over time. Measurements for allostatic load (body stress/inflammatory markers) will also be collected at the time of enrollment and at the repeat prostate biopsy visit. Detailed Description This is an open-label pilot study. The goal is to investigate the transcription and biological pathways in prostate cancer that are especially relevant to prostate cancer disparities between African American and Caucasian men. Also, to determine any significant differences in the molecular signature that exist in African American and Caucasian men in relation to their Vitamin D levels. Recruitment will be at the Urology Clinic at the Ralph H. Johnson VA Medical Center in Charleston, SC. Men who are scheduled for a Standard of Care prostate biopsy will be consented for their permission to collect an extra prostate tissue core for RNA-sequencing. After the pathology report is discussed by their Urologist, and the treatment decision is Active Surveillance, the participant is enrolled into the Intervention Phase. At that time, baseline allostatic load measurements (Blood pressure, pulse, waist/hip ratio, height, and weight for BMI) and bloodwork: (lipid panel, HgbA1c, albumin and creatinine, IL-6, CRP, and DHEA-s (inflammatory markers) plus a Vitamin D level, will be collected. Vitamin D3 soft gels (4,000 IU) daily (six months' supply) will be dispensed. A Social Determinants survey will also be dispensed for subject completion. At the Urology Standard of Care six-month follow-up appointment, the vitamin D serum level will be collected and the next six months' supply of vitamin D3 will be dispensed. At the Urology Standard of Care follow-up (repeat at 1 year) surveillance prostate biopsy, an extra prostate tissue core will be collected for RNA-sequencing. The allostatic load measurements and bloodwork will also be obtained. #Intervention - DRUG : cholecalciferol - Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year - Other Names : - vitamin D3 - PROCEDURE : Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq - RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels - PROCEDURE : Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation - Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%). - DIAGNOSTIC_TEST : Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation - Allostatic Load measurements to determine body stress compared at baseline and after one year of vitamin D3 supplementation. Also compared with RNA-seq results to determine stress response. - Other Names : - Bloodwork for HgbA1c, lipid profile, creatinine, albumin and vitamin D levels., Body measurements: Ht. Wt, BMI, waist and hip measurements for waist/hip ratio., Measurements of systolic and diastolic blood pressure and heart rate

#Eligibility Criteria: Inclusion Criteria: Recruitment: * scheduled for prostate biopsy * permission for investigators to follow subject's post biopsy diagnosis, treatment decision and follow-up care (including subsequent prostate biopsies). Enrollment: * diagnosis of prostate cancer * treatment recommendation or subject decision of Active Surveillance * agreement to supplement with vitamin D3 4,000 IU daily for approximately one year * standard of care repeat PSA at six months and surveillance prostate biopsy at one year Exclusion Criteria: * current vitamin D3 supplementation > 2,000 IU daily * inability or unwillingness to continue to participate in the study Sex : MALE Ages : - Minimum Age : 50 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT04621500

{ "NCT_ID" : "NCT05011890", "Brief_Title" : "Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®", "Official_title" : "Feasibility and Acceptability of Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®", "Conditions" : ["Lung Cancer", "Neoplasms, Lung", "Neoplasms, Pulmonary", "Pulmonary Cancer", "Pulmonary Neoplasms", "Cancer of Lung"], "Interventions" : ["Device: Moovcare® use"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to demonstrate how Moovcare®, a mobile medical application, can be used to monitor Patient-Reported Outcomes (PROs) related to cancer treatment, cancer complications, and cancer relapse in patients with lung cancer. PROs are symptoms directly reported by patients through the completion of a survey. Up to 50 patients undergoing treatment and/or surveillance for new or existing diagnoses of lung cancer at the University of North Carolina's Lineberger Comprehensive Cancer Center will be prospectively enrolled to the use of the mobile medical application Moovcare® for 6 months. Moovcare® is not FDA approved, and its role in improving clinical care is being studied through this research. Moovcare® automatically delivers electronic patient reported outcome (ePRO) surveys on common symptoms experienced by lung cancer patients. Detailed Description This is a single site nonrandomized feasibility study of approximately 50 participants on treatment and/or surveillance for new or existing diagnoses of lung cancer who will be assigned to a single-arm involving monitoring of their patient-reported outcomes using a mobile medical application. The study procedures include monitoring of patient symptoms using automated weekly PRO surveys delivered by Moovcare® and assessment of outcomes including quality of life at baseline and at monthly intervals, as well as patient satisfaction at 6 months. The clinical care team will receive an alert if the PRO survey suggests increased or worsening symptoms. The care team will follow their usual protocols for the management of symptoms. The patient clinical information will also be abstracted from the medical record to assess clinical outcomes. The provider's satisfaction survey will be assessed via surveys. #Intervention - DEVICE : Moovcare® use - Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.

#Eligibility Criteria: Inclusion Criteria: * >= 18 years * Diagnosis of lung cancer (any histology, any stage) undergoing outpatient treatment and/or surveillance/monitoring at UNC. This may include stage I and II patients who have completed lung resection and/or are undergoing radiation, stage II and III patients receiving neoadjuvant, adjuvant, or definitive chemotherapy, stage IV patients undergoing active therapy or monitoring, patients undergoing surveillance for treated or untreated stage I-III lung cancer, and both limited and extensive small cell lung cancer. The study team will request the confirmation of the lung cancer diagnosis from the managing clinician. Patients can be enrolled at any point in their lung cancer treatment trajectory (i.e., not just at initiation of first-line treatment) after a diagnosis of lung cancer has been assigned by the treating clinician. This may include patients assigned a diagnosis of lung cancer without a tissue diagnosis. * Speaks and understands English * Reliable access to the internet and email * Access to a mobile phone (or device that can receive text messages for registration) Exclusion Criteria: * Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing study procedures * Current participation in other PRO monitoring trials * Inability to read and speak English * Current incarceration Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT05011890

{ "NCT_ID" : "NCT02794558", "Brief_Title" : "Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas", "Official_title" : "A Clinical Study To Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas", "Conditions" : ["Breast Cancer"], "Interventions" : ["Device: ExAblate MRgFUS"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas Detailed Description Study specific aim is to Coagulate the tissue volume of a proven breast cancer with MRgFUS and Collect post treatment follow-up clinical and radiological data for a period of 5 years following MRgFUS for breast cancer. Safety of the treatment will be evaluated by recording and assessing the incidence and severity of device- related complications from the first visit through the 5 years follow-up period. Secondary objective of this study is to evaluate post treatment local recurrence in the same quadrant or less then 4cm from the periphery of the treated lesion, during a 5 year period following the MRgFUS treatment. Women with breast cancer in whom breast MR imaging identifies a single focal breast lesion up to 1.5 cm in diameter will be eligible for the study. #Intervention - DEVICE : ExAblate MRgFUS - MR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed. Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment. - Other Names : - Focused Ultrasound

#Eligibility Criteria: Inclusion Criteria: * Women age >= 18 years with - breast cancer proven by 14 <= age <= 20 G. core needle biopsy of the breast lesion. * No evidence of cancer at the sentinel/ Axillary node * Women in whom breast MR imaging identifies a single focal well-demarcated breast lesion less than or equal to 1.5 cm in diameter with stage T1, N0, M0 disease. * Patient received neoadjuvant care for 4 weeks such as: Hormone replacement therapy or Tamoxifen is permissible where the tumor is less than or equal to 1.5 before neoadjuvant therapy * Able and willing to give consent and able to attend all study visits. * Able to communicate sensations during the MRgFUS procedure. * Life expectancy of 5 years or more. Exclusion Criteria: * Breast cancer which was diagnosed by incisional / excisional biopsy * Contraindication to MRI (non-MRI compatible implanted metal devices). * Pregnant or lactating post partum women. * Prior XRT or laser or cryo-therapy to the target breast. * Difficulty lying prone and still for up to 210 minutes in the MR unit, e.g., COPD, heart disease, lung disease, sleep apnea or airway problems, severe asthma, severe arthritis, severe claustrophobia. * Patients with unstable cardiac status including: * Unstable angina pectoris on medication. * Patients with documented myocardial infarction within six months of protocol entry. * Congestive heart failure requiring medication. * Patients on anti-arrhythmic drugs. * Severe hypertension (diastolic BP > 100 on medication). * Patients with cardiac pacemakers. * Immunosuppressed patients, e.g., patients receiving steroids or other immunosuppressive medication, insulin-dependent diabetes mellitus, collagen vascular disease. * Patients receiving chemotherapy * Patients with history of grand mal seizures, severe cerebrovascular disease (multiple CVA or CVA within 6 months), hemolytic anemia (hematocrit < 30), or patients on dialysis. * Patients currently receiving anticoagulation therapy. * Large patients who cannot fit comfortably in the magnet, or patients > 100Kg. * Lesions difficult to target (<1 cm from skin, nipple-areola complex or the ribcage), as visualized on pre-therapy MRI. * Microcalcifications as the only sign of breast cancer on imaging studies. * Patients with breast implants. * Prior reaction to gadolinium-based contrast agent * Prior radiation to the breast, which is about to be treated. * Evidence of tumor at any location other then the targeted lesion. * Histological type of invasive micropapillary carcinoma because of cancer displacement by the needle * Mucinous carcinoma which was diagnosed by core needle biopsy because of needle cancer displacement Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02794558

{ "NCT_ID" : "NCT04066816", "Brief_Title" : "Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption", "Official_title" : "Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption", "Conditions" : ["Colo-rectal Cancer", "Colon Cancer", "Diet Habit"], "Interventions" : ["Other: Walnuts"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Briefly, this is a 28-day dietary intervention study participants will be asked to eat 2 ounces (52 grams) of walnuts every day for 3 weeks, and at the end of the study period they will come in for a colonoscopy. Participants will first start a 1-week run-in period where they will be asked to avoid foods high in ellagic acid. In addition, they will be asked to complete food surveys and two sets of 3-day dietary records, and to provide colon biopsies for this study during their routine colonoscopy, as well as a blood, and two urine and stool samples. Urine samples will be used for analysis of urolithin, ellagic acid metabolites. Stool samples will be used to assess gut microbiota changes after walnut consumption. Dietary records will be used for compliance and Food Frequency Questionnaire will be used to assess dietary habits. Lastly, the biopsy samples will be used for analysis of biomarkers and anti-inflammatory in the colon, as well as adherent microbiome to the colonic tissue. Data will be analyzed based on the urolithin phenotypes. Detailed Description The investigators propose to address the influence of ellagic acid obtained from walnuts and its microbial-derived metabolites (urolithin) on the gut microbiome and inflammation-related biomarkers in a human clinical study. Patients will be enrolled and detailed demographic and dietary information, biopsy specimens through colonoscopies, as well as fecal, blood and urine samples will be collected. The wide range of gut urolithin levels provides the rationale for our proposed studies. Will the specific urolithin phenotypes show a disparate range of chemopreventive (anti-inflammatory) response to walnut consumption? The hypothesis is that walnut ingestion in 'Phenotype A' participants (producing the highest levels of urolithin) will be associated with a beneficial anti-inflammatory response as tested in colonic mucosa and a higher abundance of bacterial species associated with ellagic acid metabolism. Although 16S ribosomal ribonucleic acid gene (rRNA) sequencing allows inexpensive bacterial identification at the genus/species level, a whole genome sequencing (mWGS) will be employed to achieve finer classification (strain level), and identify other microbes (e.g., viruses, fungi, small eukaryotes). Furthermore, mWGS targets the entire genome of each microbe (not just the 16S rRNA gene), allowing for construction of a microbial gene catalogue, including a metabolic pathway description for each sample. This will characterize the functional potential of the microbial community. Ultimately, the proposed studies will inform the application of prebiotic to enhance the formation of urolithin metabolites from ellagic acid for the prevention of inflammation-associated Colorectal Cancer, a development that would have significant translational implications. #Intervention - OTHER : Walnuts - Participants will consume 2 ounces of walnuts for 21 days

#Eligibility Criteria: Inclusion Criteria: * Men or women between the ages of 50 <= age <= 65 years who are scheduled to undergo a routine screening colonoscopy * English speaking/reading patients willing and able to provide written informed consent for study participation * Patients willing to consume walnuts for 3 weeks * Willingness to comply with all study requirements Exclusion Criteria: * Current active malignancy, previous history of gastrointestinal malignancy, or altered gastrointestinal anatomy * Current evidence or previous history of ulcerative colitis or Crohn's disease * HIV infection, chronic viral hepatitis * Allergy to walnuts or hypersensitivity to tree nuts * Use of antibiotics within the past month * Individuals with blood coagulation disorders or on anti-coagulant therapy * Treated with steroids, immunosuppressive agents or other anti-inflammatory drugs one week prior to starting intervention * Non-English-speaking patients who require an interpreter to give consent * Patients residing in the Department of Correction * Inability to comply with the protocol requirements * Any other condition that, in the opinion of the PI, might interfere with study objectives Sex : ALL Ages : - Minimum Age : 50 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: Yes

NCT04066816

{ "NCT_ID" : "NCT04522804", "Brief_Title" : "Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer", "Official_title" : "A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer", "Conditions" : ["Cancer"], "Interventions" : ["Drug: Psilocybin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["EARLY_PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. Study intervention will involve a group of six patients with one therapist per subject for a 1:1 ratio, thus significantly reducing the total number of therapist hours per subject compared to standard individual therapy protocols. Two groups of six will be treated on this trial. After the enrollment and treatment of the first group of six patients, accrual will be placed on hold to ensure subject safety. If stopping rules are not met (Section 11), the next group of six patients will be enrolled and treated on study. The study intervention will include a total of seven group therapy sessions including three 2-hour preparatory sessions, one 8-hour psilocybin session, and one two-hour integration session. The group therapy sessions will occur on a weekly basis, followed one week later by the psilocybin session. The first integration group session will occur 1-2 days following the psilocybin session. #Intervention - DRUG : Psilocybin - Psilocybin is a classic psychedelic of medium duration that is well-tolerated and has a documented safety and efficacy record that makes it uniquely well-suited to the existential issues that arise in this patient population. Psilocybin has been described as an 'existential medicine' given patient testimonials as to its acute and lasting effects on interpersonal connection, ability to more deeply engage with meaningful activities and relationships, dramatic reductions in fear of death, and a renewed sense of well-being.

#Eligibility Criteria: Inclusion Criteria: * Male or female subject aged >= 25 years. * Current diagnosis of cancer and undergoing treatment for their cancer or completed treatment within <= 26 weeks of study registration. * Life expectancy >= 3 months. * Current DSM-V diagnosis of a depression disorder including adjustment disorder with disturbance of mood. * Not taking regularly scheduled medications to treat depression and/or anxiety, including benzodiazepines, for at least 4 weeks prior to initiation of the study. * Fluent in English. * Have a high school or equivalent (e.g., GED) level of education. Volunteers without a high school or equivalent education must demonstrate reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * ECOG Performance Status <= 2. * Have a support person that would be able to escort the subject home on the evening of the psilocybin dosing session. * Adequate liver function as defined as: * Total Bilirubin <= 1.5x institutional upper limit of normal (ULN) unless elevated bilirubin is related to Gilbert's Syndrome. * AST(SGOT)/ALT(SGPT) <= 3 × institutional ULN * For female subjects: Negative pregnancy test and agreement to use highly effective contraception (as described in Section 7.2) or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women < 50 years: * Amenorrheic for >= 12 months following cessation of exogenous hormonal treatments; and * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Women >= 50 years: * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or * Had radiation-induced menopause with last menses >1 year ago; or * Had chemotherapy-induced menopause with last menses >1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * Agree to refrain from using any psychoactive drugs, including alcoholic beverages, ondansetron, cannabis, and non-routine PRN medications within 24 hours of each psilocybin administration. Exceptions include daily use of caffeine, nicotine, and opioid pain medication (see Section 6.2.2). * Agree that for one week preceding the psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals. * Agree not to use nicotine for at least 2 hours before the psilocybin administration. * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the psilocybin session. If the subject does not routinely consume caffeinated beverages, he or she must agree not to do so on the day of psilocybin administration. * Subjects requiring opioid use for pain are on a stable pain management regimen. Long-acting opioid medications (e.g., oxycodone sustained-release, morphine sustained release) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration. Exclusion Criteria: * Positive screening SARS-CoV2 (COVID-19) test, symptoms of COVID-19, or contact with someone who has tested positive for COVID-19. * Prior systemic antidepressants, anti-psychotic, or anxiolytic medication within four weeks prior to study initiation. * Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness. * Currently meeting DSM-V criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin. * Currently meeting DSM-V criteria for Cluster B Personality Disorder. * Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine). * Severe depression requiring immediate standard-of-care treatment e,g.,hospitalization. * Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator. * Cancer with known CNS involvement, or other major CNS disease. * Involvement in another investigational product for the treatment of cancer. * Known paraneoplastic syndrome or other ectopic hormone production by a tumor. * The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: * Cardiovascular disorders: * Congestive heart failure New York Heart Association Class III or IV * Unstable angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction * Uncontrolled hypertension at time of enrollment (BP>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve * Prolonged or congenital long QT syndrome (>=480 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality * Renal insufficiency as defined as creatinine clearance < 40 mL/min calculated by Cockcroft-Gault formula: * Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72) * Females: (((140-age)×weight[kg])/(serum creatinine [mg/dL]×72))×0.85 * Hepatic disorders: * Active infection including hepatitis B (known positive HBV surface antigen (HBsAg) result) or hepatitis C. * Note: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.) * Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade >= 3). * Subjects taking prohibited medications as described in Section 6.3.2. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration. Sex : ALL Ages : - Minimum Age : 25 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT04522804

{ "NCT_ID" : "NCT02323555", "Brief_Title" : "Optimize the Requirements and Preparations in Outpatient Chemotherapy", "Official_title" : "Optimize the Requirements and Preparations in Outpatient Chemotherapy", "Conditions" : ["Cancer", "IV Anticancer Therapy"], "Interventions" : ["Other: Paramedic telephone consultation"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary A prescription of injectable anticancer therapy requires the collection of medical data (interview and physical examination) and often allied (laboratory tests). This requirement is made on the day of the arrival of the patient to not prepare these treatments incorrectly. After receiving the prescription of treatment, it will take about 1 hour to prepare for pharmacy and more in times of high activity, to provide the day hospital pockets treatment, incompressible time when the patient waits to have his treatment. A process has been selected (Optima) to anticipate prescribing injectable cancer treatments and their manufacturing to reduce patient waiting times on the day of his coming François BaclesseCentre day hospital. Detailed Description Given the investigators daily activity evaluated patients received 65-70 day hospital, assessing the feasibility of the project with an internalized platform seems most relevant to completely control the process and costs. This project will consist of anticipation paramedic telephone consultation followed by a medical prescription validation will trigger the production of chemotherapy prematurely before the coming of the patient. The François Baclesse Center therefore supports the idea of an early day hospital, that is to say a prescription and production pockets of chemotherapy before the arrival of the patient in the service. This project was named PROJECT OPTIMA for 'Optimize requirements and preparations chemotherapy Ambulatory Medicine' with a paramedic telephone consultation. So this ambitious project is the first experience of a French advance routine injectable anticancer therapies, all protocols combined in a Centre for the Fight against Cancer but also in a hospital reference competent oncology and chemotherapy and whose preparation process of chemotherapy administered by injection is fully internalized and centralized. Before starting this program routine, it is essential to validate through a research project concordance between paramedic telephone consultation structured using tools and medical consultation but also define the profiles of patients and types of chemotherapy injectable likely to benefit safely from this program. This study will be conducted in two parts: • Part 1: where are compared two tools: * paramedical examination conducted by telephone two days before the arrival of the patient by a trained nurse, according to a predetermined grid, as a basis for medical decisions prescription 'virtual' or non-treatment; * medical examination performed on the day of the coming of the patient for treatment. This component will run for three months and will evaluate the rate of discrepancies between these 2 types of prescription. During this period, any prescription or administration of treatment will be validated at the end of the paramedical examination phones. This component will also detect and specify protocols suitable injectable cancer treatment and develop a typology of patients for whom the anticipation process is more efficient and more secure. Indeed, the investigators can think that the anticipation process will not be effective for all patients. For example, a patient with a brain tumor will often diminished cognitive abilities including its memory abilities. Responses to the telephone interview conducted by the nurse may be incomplete or even false due to its memory disorders. At the same time, waiting times and patient satisfaction will be evaluated and used as a reference for the second part of the study whose objective is to evaluate the benefits of this early prescription used routinely. • 2nd part: It is an assessment process routinely used after defining the profile of patients and types of treatment protocols, including the phone call from the nurse, the early prescription of chemotherapy, early production and day, medical consultation control before administration. In this step will be compared to expectations time, patient satisfaction and treatment wrongly prepared before and after the launch of Optima. Prerequisites: * All nurses to conduct telephone interviews will be trained on two days conducted by EFEC (European School of Oncology Training) whose purpose is to explain the issues of the telephone interview for resulting prescription chemotherapy for the patient. * Nurses phone platform dedicated to the call of patients will experience in service, allowing them to develop acuity to identify clues that signpost to important pieces of information for the management of patients. Feasibility: This study will be conducted in two stages for a period of three months each, which should allow in the investigators activity to include 450 patients by step, based on 3 patient came through, about 1350 came by step .. The homepage of the day hospital service capacity is 40 places for activity 65-70 patients per day. Approximately 300 patients are admitted each week with about 42 new patients each week. The investigators welcome all specialties outside of Hematology (digestive oncology, ENT and Pneumology, urogynecologic, breast screening, brain tumors and sarcomas). #Intervention - OTHER : Paramedic telephone consultation

#Eligibility Criteria: Inclusion Criteria: * Patient (e) old (e) 18 or more; * Patient (e) reached (e) from cancer and candidate (s) to treatment with injectable anticancer preparations in day hospital * solid cancerous disease for which chemotherapy is given intravenously; * Patient (e) able to communicate with the investigator or his representative; * Patient (e) Affiliate (e) a social security scheme; * Mastery of the French language; * Consent and signed. Exclusion Criteria: * Exclusive orallyanticancer treatment ; * Primary brain tumors; * Patient (e) dysphonic or having difficulty communicating orally; * Patient (e) receiving intravenous chemotherapy as part of a research protocol; * Patient (e) to receive chemotherapy whose stability is less than 24:00 (Temsirolimus) * Pathologies hematologic malignancies * Inability to undergo medical monitoring test for geographical, social or psychological reasons. * Patient (e) under guardianship or unable to give informed consent; * Patient (s) whose cognitive functions do not allow a telephone interview. * Any medical or psychological condition associated that could compromise the patient's ability to participate in the study Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02323555

{ "NCT_ID" : "NCT00869726", "Brief_Title" : "A Study for Patients With Secondary Progressive Multiple Sclerosis", "Official_title" : "A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis", "Conditions" : ["Secondary Progressive Multiple Sclerosis"], "Interventions" : ["Drug: dirucotide", "Drug: Placebo"], "Location_Countries" : ["Denmark", "Sweden", "Estonia", "Netherlands", "Latvia", "Germany", "United Kingdom", "Finland", "Spain", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis. Dirucotide is generic name for MBP8298. #Intervention - DRUG : dirucotide - 500mg, intravenous, dosed once every six months for 18 months - Other Names : - MBP8298, LY2820671 - DRUG : Placebo - intravenous, once every six months for 18 months

#Eligibility Criteria: Inclusion Criteria: * Documented history of SPMS * Absence of relapse in the 3mos prior to baseline * EDSS of 3.5 - 6.5 * Pyramidal or Cerebellar FSS greater than or equal to 3 * A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive. * Informed consent * Subject reliability and compliance Exclusion Criteria: * Diagnosis of Primary Progressive MS * Subjects have previously received MBP8298 * Recent history of malignancy, with the exclusion on basal cell carcinoma. * Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment * Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment. * Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period. * History of anaphylactic/anaphlactoid reactions to glatiramer acetate * Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant * Known allergy to Gadolinium-DTPA * Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment * Treatment at any time wtih an altered peptide ligand * Any conditions that could interfere with the performance of study specific procedures e.g.MRI * Previous randomization to this study * Known positivity for HIV, Hepatitis B, or Hepatitis C * Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos. * Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly * Known or suspected current or past alcohol or drug abuse (within the last year) * Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements * Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00869726

{ "NCT_ID" : "NCT04313374", "Brief_Title" : "Integrated Pulmonary Index and Opioid Based Patient Controlled Analgesia", "Official_title" : "Effective and Safe Morphine Dose for Patient Controlled Anesthesia in Supratentorial Craniotomies", "Conditions" : ["Brain Tumors"], "Interventions" : ["Drug: Placebo", "Drug: Morphine PCA 0,5 mg", "Drug: Morphine PCA 1 mg"], "Location_Countries" : ["Turkey"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. The investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in our previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study the investigators will use different doses of morphine based patient-controlled analgesia and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy. Detailed Description An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. In our previous study, the investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in our previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study The investigators will use different doses of morphine based patient-controlled analgesia and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy. 90 patients will randomize in 3 groups following supratentorial craniotomy. All patients will previously instruct on the patient-controlled analgesia pumps (Abbott Provider, Chicago, USA) and visual analogue scale (VAS) from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. All patients will use patient-controlled analgesia pumps for 24 hours following supratentorial craniotomy. In the Group 1 the patient-controlled analgesia pump will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. In the Group 2 the patient-controlled analgesia pump will set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. In the Group 3 the patient-controlled analgesia pump will contain placebo. The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours. If the VAS score will more than 4 the Group 3 patients will take 1 g paracetamol every 6 hours. All patients will be observed by the Integrated Pulmonary Index (IPI). It is a new device that provides to recognise in a patients respiratory status. This software tool is a single index value ranging from 1 to 10 based on 4 physiological parameters: end tidal carbon dioxide, respiratory rate, oxygen saturation, pulse rate. Patients will asses at 10th minute, 1, 2, 6, 12, and 24 hours postoperatively. Sedation will evaluate according to Ramsay score 20. VAS scores, total morphine consumption, Ramsay score, blood pressure, heart rate and respiratory rate, the IPI score will record at each time pain will evaluate. Postoperative side effects, including rash, pruritus, nausea and vomiting will record at the same intervals and defined by a scale with 0 = absent or 1 = present. Moreover the lowest IPI score, the apnea count (longer than 30 seconds) and the count of the desaturation events will record in the postoperative 24 hours. The 3 Groups will compare with respect to VAS scores, morphine consumption, IPI scores, the apnea count, the desaturation events and morphine related side effects during the 24 hours following supratentorial craniotomy. #Intervention - DRUG : Morphine PCA 1 mg - PCA will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. - Other Names : - Morphine sulphate 1 mg - DRUG : Morphine PCA 0,5 mg - PCA set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. - Other Names : - Morphine sulphate 0,5 mg - DRUG : Placebo - the PCA will contain placebo - Other Names : - serum physiologic, dexketoprofen trometamol, paracetamol

#Eligibility Criteria: Inclusion Criteria: , brain tumors, elective supratentorial craniotomies, * Conscious patients * Elective supratentorial craniotomies * ASA I-III Exclusion Criteria: * Unconscious postoperatively * Chronic pain * Opioid, dexketoprofen or paracetamol allergy * Delirium * Renal insufficiency * Alcohol, opioid dependency * Transsphenoidal pituitary surgery Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD Accepts Healthy Volunteers: Yes

NCT04313374

{ "NCT_ID" : "NCT00421512", "Brief_Title" : "A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients", "Official_title" : "A Phase I Study of Bevacizumab and Sunitinib in Metastatic Renal Cell Carcinoma Patients", "Conditions" : ["Metastatic Renal Cell Carcinoma", "Kidney Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test the safety of bevacizumab and sunitinib given in combination for kidney cancer. The drugs act to stop blood vessel growth but in different ways. They have not been studied together in a previous study. We also want to find out what effects (good and bad) the combination of bevacizumab and sunitinib have on you and your tumor. Detailed Description To assess the maximum tolerated dose and overall safety and tolerability of sunitinib administered in combination with bevacizumab for the treatment of patients with metastatic renal cell carcinoma. To assess antitumor activity of the combination of sunitinib and bevacizumab. To evaluate serum levels of vascular endothelial growth factor (VEGF) in patients treated with sunitinib and bevacizumab. Study Design: This is a single center, open-label, Phase 1 study of sunitinib in combination with bevacizumab in patients with advanced metastatic renal cell carcinoma. This study is designed to confirm that the two agents can be administered safely in combination. Patients will begin treatment with bevacizumab on Day 0 and sunitinib on Day 1. Bevacizumab will be administered intravenously every two weeks. Sunitinib will be given orally on a 4 weeks on, 2 weeks off schedule. DLT determination will be based on toxicities observed in Cycles 1 - a cycle is defined by sunitinib dosing (6 weeks). Once the MTD for the combination has been identified, 10 additional patients will be enrolled at the MTD to further assess safety and efficacy. Patients will be treated with bevacizumab and sunitinib until there is disease progression, significant toxicity or withdrawal of patient consent. The maximum treatment duration is 24 months. #Intervention - DRUG : Bevacizumab and Sunitinib - On Cycle 1, Day 0, patients will begin treatment with bevacizumab. Sunitinib will begin on Day 1. The starting dose for sunitinib will be 25mg orally daily. sunitinib will be given in a four weeks on-two weeks off schedule. Bevacizumab will begin on Day 0 and will be administered every two weeks at 10mg/kg. A cycle of therapy is 6 weeks. The sunitinib dose escalation portion of the trial will be performed to determine the MTD of sunitinib given in combination with bevacizumab. Once the MTD has been determined, 10 additional patients will be treated at the MTD of sunitinib in combination with bevacizumab.

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed renal cell carcinoma (of any histological subtype) and with metastases. Patients with unresected primary tumors may be enrolled as long as evidence of metastatic disease is also present. * Evidence of unidimensionally measurable disease (i.e., greater than or equal to 1 malignant tumor mass that can be accurately measured in at least 1 dimension greater than or equal to 20 mm with conventional computerized tomography [CT] or magnetic resonance imaging [MRI], or greater than or equal to 10 mm with spiral CT scan [if spiral CT scan is used, minimum lesion size should be twice the reconstruction interval used, e.g., if reconstruction size is 7 mm, lesion size should be greater than or equal to 14 mm]). * Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable. * Male or female, 18 years or older. * ECOG performance status 0 or 1. * Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade less than or equal to 1. * Adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) less than or equal to 1.5 x upper limit of normal (ULN) * Total serum bilirubin less than or equal to 1.5 mg/dL * Total white blood cell count greater than or equal to 3000 cells/µL * Absolute neutrophil count (ANC) greater than or equal to 1500/µL * Platelets greater than or equal to 100,000/µL * Hemoglobin greater than or equal to 9.0 g/dL * Serum calcium less than or equal to 12.0 mg/dL * Serum creatinine less than or equal to 2.0 x ULN * PT less than or equal to 1.5 ULN * Urine protein:creatinine ratio less than or equal to 1.0 at screening * Negative pregnancy test (only in women of childbearing age) * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: * Patients eligible for the higher priority IRB protocol #07 <= age <= 066 * Major surgery, open biopsy, traumatic injury, radiation or systemic therapy within 4 weeks of starting the study treatment. Anticipation of major surgical procedure during the study. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated. * More than 2 prior systemic therapies for metastatic RCC. * Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0. * NCI CTCAE grade 3 hemorrhage within the past 1 month. * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0. * History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis. * Any of the following within the 12 months prior to study drug administration: * severe/unstable angina, MI, CABG, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or peripheral vascular disease. * Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males and >470 msec for females. * Blood pressure > 150/90mmHg * Evidence of bleeding diathesis or coagulopathy * Serious, non-healing wound, ulcer or bone fracture * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. * Current treatment on another therapeutic clinical trial. * Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. * Receipt of any investigational agent within 4 weeks prior to study entry. * History of severe hypersensitivity reaction to bevacizumab or to any other component of bevacizumab. * Prior treatment with sunitinib, bevacizumab * Prior sorafenib given less than 8 weeks prior to study entry. * Unresolved symptoms or signs related to sorafenib within 8 weeks prior to study entry. * Use of therapeutic doses of coumadin. * Inability to comply with study and/or follow-up procedures Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00421512