Kidney Cancer Clinical Trial
Official title:
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
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate
the white blood cells, including natural killer cells, to kill melanoma or kidney cancer
cells. Giving genistein together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving genistein together with
interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
these regimens.
- 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
days 10-19.
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
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