About 124,538 results

Biological Therapy in Treating Patients With Metastatic Melanoma

May 9th, 2010 - OBJECTIVES: Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma. Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients. Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients. OUT...

Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer

Jun 20th, 2013 - OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine in combination with radiation therapy to patients with locally advanced and/or unresectable adenocarcinoma of the pancreas. II. Determine the dose limiting toxic effects of this combination therapy in these patients. III. Evaluate the ability of these patients to tolerate induction and then maintenance therapy with gemcitabine p...

SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma

Aug 28th, 2014 - OBJECTIVES: I. Determine the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposi's sarcoma. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients. V. Determ...

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

Feb 10th, 2013 - OBJECTIVES: I. Assess the toxicity associated with repeated vaccination with recombinant vaccinia virus expressing prostate-specific antigen (rV-PSA) in patients with metastatic adenocarcinoma of the prostate. II. Determine the optimal dose of rV-PSA given at monthly intervals based on cellular and hormonal immunity. III. Determine whether vaccination with rV-PSA is associated with anti-tumor a...

Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Jul 18th, 2016 - OBJECTIVES: Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy. Determine the toxicity of this regimen in these patients. Determine the overall and failure-free survival of patients treated with this regimen. Determi...

Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients

Jun 24th, 2013 - Although patient reminder/recall systems have been shown to be effective at improving vaccination coverage levels for infants and younger children, little is known about the effectiveness of such systems for increasing immunization rates in adolescent populations. The process of reminder/recall in adolescents, and vaccination of adolescents overall, presents particular challenges. Adolescents a...

Combination Chemotherapy in Treating Patients With Colorectal Cancer

Jul 12th, 2012 - OBJECTIVES: Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil, leucovorin calcium, and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer. Determine the antitumor activity of this regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified a...

Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

Jun 4th, 2013 - OBJECTIVES: Determine the recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with irinotecan-refractory advanced colorectal cancer. Determine the safety and tolerance of this drug in these patients. Determine any antitumor activity of this drug in these patients. Determine the objective response rate, response duration, and time to progression in patients treated wi...

A Dose-escalation Study in Subjects With Advanced Malignancies

Nov 21st, 2017 - This is an open label, dose escalation study using a 3 + 3 design to determine if INCB028060 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. Doses will be escalated unless a dose-limitin...

Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia

Apr 27th, 2017 - OBJECTIVES: Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia. Determine the toxicity of this vaccination in these patients. OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intr...

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

May 21st, 2014 - OBJECTIVES: I. Determine the maximum tolerated dose of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) fusion protein when combined with melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 in patients with completely resected stage III or IV melanoma. II. Determine the toxicity and safety of this...

Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

Jun 19th, 2013 - OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer. II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen. III. Evaluate the toxicity of this regimen in these patients. ...

Sodium Butyrate For Improving Cognitive Function In Schizophrenia

May 1st, 2017 - The persistent cognitive deficits which can be appreciated across the course of SZ, from prodromal to chronic SZ, may be the most important underlying dysfunction in preventing functional, occupational, and social recovery in SZ compared to other symptom domains. Sodium butyrate is a short chain fatty acid and binds to the zinc site of histone deacetylases (HDAC). The inhibition of HDAC results...

Photodynamic Therapy in Treating Patients With Skin Cancer

Jan 30th, 2013 - OBJECTIVES: Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas. Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients. Compare the results of tissue fluorescence with surface fluorescence measurements in these patients. OUTLINE: This is a...

Chemotherapy in Treating Patients With Solid Tumors

Jul 2nd, 2013 - OBJECTIVES: I. Evaluate the safety and plasma concentration profiles of oblimersen (G3139) administered alone or in combination with docetaxel in patients with advanced solid tumors expressing the bcl-2 oncogene. II. Determine the plasma concentration profiles, maximum tolerated dose (MTD), and/or optimal biologic dose (OBD) of this treatment regimen in these patients. III. Determine the antitu...

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Mar 25th, 2018 - The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids. Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Mar 27th, 2011 - OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum. OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours p...

A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

Mar 5th, 2015 - The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

Sep 11th, 2014 - Scientific Context: High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. Th...

FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer

Jul 1st, 2013 - PRIMARY OBJECTIVES: I. Determine the radiographic response rate (complete response and partial response) in patients with refractory adenocarcinoma of the stomach or gastroesophageal junction treated with FR901228 (depsipeptide). SECONDARY OBJECTIVES: I. Determine the median time to progression and progression-free survival of patients treated with this drug. II. Determine the grade 3 and 4 tox...