Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option
• •Dacarbazine is indicated as first line chemotherapy
• •At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2
• •No history of brain metastases
• •-Prior/Concurrent Therapy--
• •Biologic therapy: At least 4 weeks since prior biologic therapy
• •Chemotherapy: See Disease Characteristics; No prior chemotherapy
• •Endocrine therapy: No concurrent immunosuppressive drugs
• •Radiotherapy: At least 4 weeks since prior radiotherapy
• •Surgery: At least 2 weeks since prior major surgery
• •Other: No other concurrent anticancer drug therapy or experimental therapy
• •-Patient Characteristics--
• •Age: 18 and over
• •Performance status: Karnofsky 80-100%
• •Life expectancy: At least 24 weeks
• •Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
• •Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN
• •Renal: Creatinine no greater than 2.0 mg/dL
• •Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
• •Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders