Kidney Cancer Clinical Trial
Official title:
A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy With Subcutaneous Interleukin-2 and Maxamine in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer
cells. Histamine dihydrochloride may prolong survival and improve quality of life in
patients with metastatic kidney cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or
without histamine dihydrochloride in treating patients who have metastatic kidney cancer.
OBJECTIVES:
- Determine the clinical efficacy and safety of subcutaneous (SC) histamine
dihydrochloride given in conjunction with SC recombinant human interleukin-2 in
patients with stage IV renal cell carcinoma in terms of survival at 1 year, objective
tumor response rate, duration of response, and median survival.
OUTLINE: This is a randomized, open label study. Patients are randomized to receive
interleukin-2 (IL-2) with or without histamine dihydrochloride.
- Arm I: Patients receive IL-2 subcutaneously (SC) once daily and histamine
dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest.
- Arm II: Patients receive IL-2 as in arm I. Treatment continues for a minimum of 2
courses in both arms in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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