Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic melanoma
• No ocular or mucosal melanoma
• Must meet one of the following criteria:
• Failed standard or salvage therapy
• Ineligible for standard therapy due to concurrent illness
• Declined standard therapy
• Received at least 1 prior therapy for metastatic disease
• Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases
• No leptomeningeal metastases
• At least 1 documented site of bidimensionally measurable disease by MRI or CT scan
• Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Absolute neutrophil count greater than 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL
• No coagulation disorder such as thrombophlebitis

Hepatic:

• Bilirubin less than 2.0 mg/dL
• AST and ALT less than 3 times upper limit of normal (ULN)
• Alkaline phosphatase less than 3 times ULN

Renal:

• Creatinine less than 1.5 times ULN
• BUN less than 1.5 times ULN

Cardiovascular:

• Ejection fraction at least 45%
• No active ischemia
• No unstable angina
• No uncontrolled congestive heart failure

Pulmonary:

• Normal pulmonary function tests within the past month
• FEV1 or FVC more than 65% predicted
• No uncontrolled pulmonary embolism

Gastrointestinal:

• No frequent vomiting
• No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)

Other:

• No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks
• No uncontrolled cortical dysfunction
• No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality)
• No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
• No significant psychiatric disease that would preclude study compliance
• No AIDS-related illness
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Biologic therapy:

• More than 1 month since prior biologic therapy or immunotherapy

Chemotherapy:

• More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy:

• At least 4 weeks since prior steroid therapy or steroid-containing compounds
• At least 2 weeks since prior topical or inhaled steroids

Radiotherapy:

• See Disease Characteristics
• More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery

Surgery:

• At least 1 week since prior surgery