Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed metastatic melanoma
• * No ocular or mucosal melanoma
• Must meet one of the following criteria:
• * Failed standard or salvage therapy
• * Ineligible for standard therapy due to concurrent illness
• * Declined standard therapy
• Received at least 1 prior therapy for metastatic disease
• Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases
• No leptomeningeal metastases
• At least 1 documented site of bidimensionally measurable disease by MRI or CT scan
• * Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• ECOG 0-2
• Life expectancy:
• More than 3 months
• Hematopoietic:
• WBC at least 3,000/mm\^3
• Absolute neutrophil count greater than 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10 g/dL
• No coagulation disorder such as thrombophlebitis
• Hepatic:
• Bilirubin less than 2.0 mg/dL
• AST and ALT less than 3 times upper limit of normal (ULN)
• Alkaline phosphatase less than 3 times ULN
• Renal:
• Creatinine less than 1.5 times ULN
• BUN less than 1.5 times ULN
• Cardiovascular:
• Ejection fraction at least 45%
• No active ischemia
• No unstable angina
• No uncontrolled congestive heart failure
• Pulmonary:
• Normal pulmonary function tests within the past month
• FEV1 or FVC more than 65% predicted
• No uncontrolled pulmonary embolism
• Gastrointestinal:
• No frequent vomiting
• No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
• Other:
• No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks
• No uncontrolled cortical dysfunction
• No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality)
• No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
• No significant psychiatric disease that would preclude study compliance
• No AIDS-related illness
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Biologic therapy:
• More than 1 month since prior biologic therapy or immunotherapy
• Chemotherapy:
• More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• Endocrine therapy:
• At least 4 weeks since prior steroid therapy or steroid-containing compounds
• At least 2 weeks since prior topical or inhaled steroids
• Radiotherapy:
• See Disease Characteristics
• More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery
• Surgery:
• At least 1 week since prior surgery