Kidney Cancer Clinical Trial
Official title:
Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell
carcinoma (kidney cancer) cells.
PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works
in treating patients with metastatic renal cell carcinoma that has not responded to previous
low-dose intravenous or subcutaneous interleukin-2.
OBJECTIVES:
- Determine the response rate (complete, partial, and minor) in patients with metastatic
renal cell carcinoma who failed prior low-dose intravenous or subcutaneous
interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
- Determine the overall survival, disease-free survival, and time to progression in
patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days
later by another 15 doses (course 1).
Patients are assesed for response 2 months after initiation of treatment. Patients with
responding or stable disease receive a second course of therapy. Patients with an ongoing
response receive subsequent courses of treatment in the absence of unacceptable toxicity.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Primary Purpose: Treatment
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