Biological Therapy in Treating Patients With Metastatic Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility 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
Sites / Locations
- Fred Hutchinson Cancer Research Center