S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed malignant cutaneous melanoma
• * Unresectable, stage IV disease
• * Unknown primary allowed
• Measurable or non-measurable disease
• * If all known sites of disease are within a previously irradiated port, disease progression must be clearly demonstrated
• No brain metastases by CT scan or MRI within the past 42 days
• * Prior brain metastasis allowed provided both of the following criteria are met:
• * Completely resected and free of disease
• * Treated with whole brain radiotherapy and completed treatment at least 28 days ago
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Zubrod 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL (transfusions allowed)
• Hepatic
• Bilirubin ≤ 3 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
• Renal
• Creatinine ≤ 1.5 times ULN
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after study participation
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
• No history of allergic reaction to dacarbazine
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior thalidomide for stage IV disease
• At least 28 days since prior biological therapy
• At least 28 days since prior immunotherapy
• At least 28 days since prior adjuvant interferon alfa
• Chemotherapy
• No prior temozolomide or dacarbazine for stage IV disease
• At least 28 days since prior chemotherapy
• Endocrine therapy
• At least 28 days since prior hormonal therapy
• Radiotherapy
• See Disease Characteristics
• At least 28 days since prior radiotherapy
• Surgery
• See Disease Characteristics
• At least 28 days since prior surgery for primary and stage IV disease
• Other
• No more than 1 prior systemic therapy regimen for stage IV disease
• At least 28 days since other prior systemic therapy