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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Bloomington Hospital
Bloomington, Indiana, United States
Baptist Regional Cancer Center - Knoxville
Knoxville, Tennessee, United States
St. Joseph Regional Cancer Center
Bryan, Texas, United States
Start Date
January 1, 1996
Primary Completion Date
January 1, 2000
Completion Date
January 1, 2000
Last Updated
May 12, 2011
40
ESTIMATED participants
aldesleukin
BIOLOGICAL
recombinant interferon alfa
BIOLOGICAL
Lead Sponsor
Hoag Memorial Hospital Presbyterian
Collaborators
NCT00026884
NCT07485114
Data Source & Attribution
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