Expired Study
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Seattle, Washington 98109


Purpose:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.


Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma. - Determine the safety and toxicity of this regimen in these patients. - Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients. Secondary - Determine the antitumor effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+ antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1, tyrosinase, or gp100. Patients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes. Cohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells 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. Patients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12 weeks. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - HLA type expressing one of the following class II alleles: - DRB1*0401 - DRB1*0404 - DRB1*1501 - DPB1*0401 - DPB1*0402 - Tumor expresses tyrosinase - Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed - No CNS metastases - Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - Karnofsky 70-100% Life expectancy - More than 16 weeks Hematopoietic - WBC greater than 4,000/mm^3 - Absolute neutrophil count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hematocrit greater than 30% Hepatic - SGOT no greater than 3 times upper limit of normal - INR no greater than 1.5 due to hepatic dysfunction - No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater Renal - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 60 mL/min - Calcium no greater than 12 mg/dL Cardiovascular - No significant cardiac abnormalities*, defined by any 1 of the following: - Congestive heart failure - Clinically significant hypotension - Symptoms of coronary artery disease - Cardiac arrhythmias present on EKG requiring drug therapy NOTE: *Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram Pulmonary - No clinically significant pulmonary dysfunction - FEV1 at least 1.0 L OR - FEV1 at least 60% - DLCO at least 55% (corrected for hemoglobin) Immunologic - No acquired or hereditary immunodeficiency - No autoimmune disease - No active infection - No oral temperature greater than 38.2 degrees C within the past 72 hours - No systemic infection requiring chronic maintenance or suppressive therapy - HIV negative Other - No retinitis or choroiditis - No history of seizures - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy) Chemotherapy - At least 4 weeks since prior chemotherapy (standard or experimental) and recovered Endocrine therapy - No concurrent systemic steroids except for toxicity management Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - Not specified Other - At least 4 weeks since prior immunosuppressive therapy - More than 4 weeks since prior experimental drugs and recovered - No concurrent pentoxifylline - No other concurrent investigational agents


NCT ID:

NCT00045357


Primary Contact:

Study Chair
Cassian Yee, MD
Fred Hutchinson Cancer Research Center


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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