Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed malignant melanoma
• •* Unresectable stage III or stage IV disease
• •* Ocular, mucosal, or cutaneous melanoma
• •Measurable disease
• •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 OR
• •Creatinine clearance at least 60 mL/min
• •Cardiovascular:
• •No history of severe cardiovascular disease
• •No myocardial infarction within the past 6 months
• •No unstable angina
• •No New York Heart Association class III or IV heart disease (congestive heart failure)
• •No ventricular tachyarrhythmias
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •HIV negative
• •No AIDS-related illness
• •No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
• •No serious infection requiring IV antibiotics
• •No psychiatric disorder requiring ongoing therapy or medication
• •No nonmalignant illness or other medical condition that would preclude study
• •No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 4 weeks since prior biologic therapy or immunotherapy and recovered
• •No concurrent immunotherapy
• •Chemotherapy:
• •No prior dacarbazine
• •No prior temozolomide
• •No other concurrent chemotherapy
• •Endocrine therapy:
• •No concurrent systemic corticosteroids
• •Radiotherapy:
• •At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery
• •At least 3 weeks since prior radiotherapy to the brain for brain metastases
• •Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression
• •Recovered from prior radiotherapy
• •No concurrent radiotherapy
• •Surgery:
• •At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered