High-Dose Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer or Melanoma
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.
Biological: recombinant interferon alfa
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Start Date:||January 1996|
|Study Completion Date:||January 2000|
|Primary Completion Date:||January 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003091
|United States, California|
|Hoag Memorial Hospital Presbyterian|
|Newport Beach, California, United States, 92658|
|United States, Indiana|
|Bloomington, Indiana, United States, 47402|
|United States, Tennessee|
|Baptist Regional Cancer Center - Knoxville|
|Knoxville, Tennessee, United States, 37901|
|United States, Texas|
|St. Joseph Regional Cancer Center|
|Bryan, Texas, United States, 77802|
|Study Chair:||Robert O. Dillman, MD, FACP||Cancer Biotherapy Research Group|