Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
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.
Biological: High-dose interleukin-2
Dietary Supplement: genistein
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright) [ Time Frame: Days 1, 8, 10, 15, 22, and 24 of treatment ] [ Designated as safety issue: No ]
- Circulating plasma levels of TGF-beta [ Time Frame: Prior to and at end of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
|Experimental: Genistein and Interleukin-2||
Biological: High-dose interleukin-2
Administered days 1-5, and 15-19; the patient will receive 600,000 IU/kg IL-2 by intravenous infusion over 15 minutes every 8 hours (on day 1 and day 15, patients will receive a maximum of 2 doses per day; on all other days in the cycle patients will receive a maximum of 3 doses per day)
Other Names:Dietary Supplement: genistein
Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)
Other Name: isoflavone
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276835
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Timothy M. Kuzel, MD||Robert H. Lurie Cancer Center|