Interleukin-2 in Metastatic Melanoma

In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per
week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt
to determine the response rate, median duration of response, and median survival. The dose
intensity of this schedule would allow a patient treated on this regimen to achieve the
target threshold (> 1440 million IU/m2/year).

Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have
received prior systemic therapy or may be previously untreated.

2. Patients must have bi-dimensional measurable disease on physical exam or radiologic
studies.

3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.

4. 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.

5. 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.

6. Patients with elevated temperatures > 100.5 F must have sources of occult infection
excluded.

7. Patients must be felt to have recovered from effects of prior therapy, such as > 2
weeks after prior chemotherapy.

8. Patient consent must be obtained prior to entrance onto study.

9. Women of childbearing potential must have a negative pregnancy test and must take
adequate precautions to prevent pregnancy during treatment

Exclusion Criteria:

1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as
cyclosporin or methotrexate.

2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by
immune-based therapy.

3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.

4. Lactation or pregnancy.

5. 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.

6. Current brain metastasis.