Kidney Cancer Clinical Trial
Official title:
Treatment of Metastatic Renal Cell Carcinoma and Melanoma With Subsequential High-Dose Subcutaneous Interferon Alfa-2b and High-Dose Bolus and Continuous Intravenous Interleukin-2
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may
stimulate a person's white blood cells to kill kidney cancer or melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose interferon alfa and
interleukin-2 in treating patients with metastatic kidney cancer or melanoma.
OBJECTIVES: I. Determine the safety, efficacy, and antitumor activity of high dose
interferon alfa-2b and interleukin-2 in patients with metastatic renal cell carcinoma or
melanoma. II. Determine the toxic effects of interferon alfa-2b and interleukin-2 in these
patients.
OUTLINE: This is an open label study. Patients receive subcutaneous interferon alfa-2b on
days 1-4. Patients are hospitalized and receive bolus infusions of interleukin-2 (IL-2)
followed by a continuous infusion on days 5-7. Patients are observed at least 12 hours
following IL-2 treatment. Treatment is repeated every 4 weeks until disease progression or
up to a maximum of six cycles. Patients are followed every 2 months for one year, then for
survival.
PROJECTED ACCRUAL: If at least 1 response is seen in the first 14 patients in each group, a
maximum of 40 patients per group will be accrued.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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