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

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