Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Registration Number
- NCT00018941
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. It is not yet known which regimen of interleukin-2 is most effective for kidney cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer.
- Detailed Description
OBJECTIVES: I. Determine the response rate and overall survival of patients with metastatic renal cell carcinoma treated with either low-dose or high-dose intravenous interleukin-2 (IL-2) or subcutaneous IL-2. II. Compare the toxic effects of these 3 regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to presence of renal tumor (yes vs no). Patients are randomized to one of three treatment arms. Arm I: Patients receive low dose interleukin-2 (IL-2) IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm II: Patients receive high dose IL-2 IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm III: Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive an additional complete course of therapy.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Surgery Branch
🇺🇸Bethesda, Maryland, United States
Surgery Branch🇺🇸Bethesda, Maryland, United States