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

Inclusion Criteria

• •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