A Pilot Study of Denileukin Diftitox in Combination With High-Dose IL-2 for Patients With Metastatic Renal Cell Carcinoma
- Determine the toxic effects of denileukin diftitox and high-dose interleukin-2 in
patients with metastatic renal cell cancer.
- 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
- 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
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
The primary objective is to assess for toxicity
To assess the toxicity
After each cycle of therapy and 30 days after the last treatment.
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|