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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
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