Kidney Cancer Clinical Trial
Official title:
A Pilot Study of Denileukin Diftitox in Combination With High-Dose IL-2 for Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry
tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the
white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with
interleukin-2 may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox
and interleukin-2 in treating patients with metastatic kidney cancer.
OBJECTIVES:
Primary
- Determine the toxic effects of denileukin diftitox and high-dose interleukin-2 in
patients with metastatic renal cell cancer.
Secondary
- Perform transforming growth factor (TGF)-beta promoter and TGF-beta receptor genotyping
to search for variants that may be associated with tumor response to therapy.
- Determine the overall response rate (partial and complete) in patients treated with
this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a randomized, pilot study.
The first 3 patients enrolled in the study receive high-dose interleukin-2 (IL-2) IV over 15
minutes, 3 times daily, on days 1-5 and 15-19 and denileukin diftitox IV over 15-60 minutes
once daily on days 8-10. If no dose-limiting toxicity occurs after receiving denileukin
diftitox, subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive denileukin diftitox (at a higher dose than for the first 3
patients enrolled in the study) IV over 15-60 minutes once daily on days -4 to -2 and
high-dose IL-2 IV over 15 minutes, 3 times daily, on days 1-5 and 15-19.
- Arm II: Patients receive high-dose IL-2 as in arm I and denileukin diftitox (at a
higher dose than for the first 3 patients enrolled in the study) IV over 15-60 minutes
at a higher dose once daily on days 8-10.
All patients may receive additional treatment with IL-2 alone in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 4
years.
PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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