Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

The current study will test single agent IL-2 given daily for 4 doses every 3 weeks for a
total of 12 doses in an outpatient setting in stage IV melanoma and kidney cancer to attempt
to determine the response rate, how long the responses last, and median survival of this
regimen in these two diseases. Responding patients and those with absence of disease
progression may receive additional cycles of therapy every 3 weeks.

Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic kidney cancer or malignant
melanoma Patients may be either newly diagnosed with metastatic disease or may have
received prior treatment for metastatic kidney cancer.

2. Patients must have 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 < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl.

5. Patients must undergo a low-level cardiac stress test (or similar cardiac evaluation
such as dobutamine stress echocardiogram or radionuclide-based stress test) 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.

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.