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