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

Study Overview
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Brief Summary
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The current study will test single agent IL-2 in stage IV melanoma and kidney cancer.

Detailed Description
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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.

Official Title
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Phase II Trial of Outpatient Intravenous Interleukin-2 in Malignant Melanoma and Metastatic Kidney Cancer

Conditions
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Melanoma, Metastatic Kidney Cancer

Intervention / Treatment
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* Drug: Interleukin-2 (IL-2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Patients must have 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 < 2 x upper limit of normal; serum creatinine < 2.0 mg/dl. 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interleukin-2 (IL-2)|Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| how long the tumor shrinkage lasts |  | 9 weeks |