Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed metastatic malignant melanoma that is considered unresectable
• * Stage III or IV ocular, mucosal, or cutaneous melanoma
• Measurable disease
• No CNS disease (phase I only)
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Karnofsky 70-100%
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 150,000/mm\^3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT/SGPT no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN
• Renal:
• Creatinine no greater than 1.5 times ULN
• Cardiovascular:
• No history of active angina
• No myocardial infarction within past 6 months
• No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 4 weeks before and after study
• No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
• No preexisting neurotoxicity grade 2 or greater
• No serious concurrent infections treated with antibiotics
• No nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study
• No psychiatric disorders that would preclude study compliance
• No other medical condition or reason that would preclude study
• No other malignancy within the past 2 years except:
• * Nonmelanoma skin cancer
• * Carcinoma in situ of the cervix
• * History of T1a or b prostate cancer detected incidentally at TURP and comprising less than 5% of resected tissue with PSA normal since TURP
• No AIDS related illness
• HIV negative
• PRIOR CONCURRENT THERAPY:
• Recovered from prior therapy
• Biologic therapy:
• At least 4 weeks since prior biologic therapy
• At least 4 weeks since prior immunotherapy
• No concurrent immunotherapy
• Chemotherapy:
• No prior systemic chemotherapy for metastatic melanoma
• No other concurrent chemotherapy
• Endocrine therapy:
• Not specified
• Radiotherapy:
• At least 4 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery
• At least 3 weeks since prior radiotherapy to the brain if brain metastases from melanoma
• Prior radiotherapy to only indicator lesion allowed provided recent evidence of disease progression at that site
• No concurrent radiotherapy
• Surgery:
• At least 2 weeks since prior surgery requiring general anesthesia