A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma

Fecha de inicio: 1 de septiembre de 2003

DISEASE CHARACTERISTICS: Diagnosis of metastatic melanoma Solitary pulmonary nodule may not be sole site of metastatic disease No disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, or iliac nodes) sites only Measurable disease Disease progression during or after prior interleukin-2 (IL-2)-based therapy OR ineligible for high-dose IL-2 therapy Metastatic disease amenable to complete surgical resection Less than 5% estimated mortality from surgery Prior complete metastasectomy allowed provided disease did not recur within 6 months after surgery No primary ocular or mucosal melanoma No brain metastases PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 OR Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No coagulation disorder Hepatic Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 70 mL/min No major medical illness of the renal system Cardiovascular No major medical illness of the cardiovascular system Pulmonary No major medical illness of the respiratory system Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active systemic infection No form of primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No concurrent palliative radiotherapy Surgery See Disease Characteristics No concurrent palliative surgery Other More than 3 weeks since prior therapy for melanoma (except surgery) No other concurrent therapy for melanoma