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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert O. Dillman, MD, FACP
Study Chair
Cancer Biotherapy Research Group
United States: Federal Government
CDR0000065795
NCT00003091
January 1996
January 2000
Name | Location |
---|---|
Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
Bloomington Hospital | Bloomington, Indiana 47402 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
St. Joseph Regional Cancer Center | Bryan, Texas 77802 |