Spots Global Cancer Trial Database for High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma

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Trial Identification

Brief Title: High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma

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

Study ID: NCT00003091

Conditions

Kidney Cancer

Melanoma (Skin)

Interventions

aldesleukin

recombinant interferon alfa

Study Description

Brief Summary: 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.

Detailed Description: 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.