Kidney Cancer Clinical Trial
Official title:
Phase III Randomized Study of Intravenous Low Dose Versus Intravenous High Dose Versus Subcutaneous Interleukin-2 for Metastatic Renal Cell Carcinoma
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.
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.
;
Primary Purpose: Treatment
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