Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00018941|
Recruitment Status : Completed
First Posted : May 5, 2003
Last Update Posted : June 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Biological: aldesleukin||Phase 3|
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.
|Study Type :||Interventional (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|
|Study Start Date :||April 1991|
|Actual Study Completion Date :||May 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018941
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||James C. Yang, MD||NCI - Surgery Branch|