A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma
- Measure the differences in peak and duration of the expansion of circulating
CD4-positive, CD8-positive, and CD4-, CD25-, and CD56-positive cells (dim and bright)
at different time points during therapy with interleukin-2 (IL-2) alone and plus
genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma.
- Evaluate the differences in peripheral blood mononuclear cell gene expression following
high-dose IL-2 with and without genistein and compare to baseline.
- Determine the overall response rate (partial and complete) in patients treated with
- Determine the safety and toxic effects of these regimens in these patients.
- Determine the time to progression in patients treated with these regimens.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and
3 times daily on days 2-5 and 16-19. Patients also receive oral genistein twice daily on
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)
Days 1, 8, 10, 15, 22, and 24 of 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|