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 Stage IV disease HLA-A1, -A2, and -A3 positive MAGE-1 or -3 positive by histology Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan No CNS metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status Karnofsky 80-100% Life expectancy More than 6 months Hematopoietic Not specified Hepatic Bilirubin ≤ 1.6 mg/dL SGOT ≤ 3 times upper limit of normal PT ≤ 1.5 times control Renal Creatinine ≤ 2.0 mg/dL Calcium ≤ 12 mg/dL Cardiovascular No congestive heart failure No clinically significant hypotension No symptoms of coronary artery disease No cardiac arrhythmias on electrocardiogram requiring drug therapy Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram Pulmonary No clinically significant pulmonary dysfunction by medical history or physical examination FEV_1 ≥ 60% of normal DLCO ≥ 55% (corrected for hemoglobin) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No retinitis or choroiditis No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours No systemic infection requiring chronic maintenance or suppressive therapy PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy) Chemotherapy At least 3 weeks since prior standard or experimental chemotherapy 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed Endocrine therapy No concurrent systemic steroids (except for toxicity management) Radiotherapy At least 3 weeks since prior radiotherapy Surgery Not specified Other At least 3 weeks since prior immunosuppressive therapy No concurrent pentoxifylline No other concurrent investigational agents
Sites / Locations
- Fred Hutchinson Cancer Research Center