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