Interleukin-2 in Metastatic Melanoma

Inclusion Criteria:

Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
Patient consent must be obtained prior to entrance onto study.
Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

Exclusion Criteria:

Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
Lactation or pregnancy.
Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
Current brain metastasis.