Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
- Conditions
- Melanoma (Skin)Kidney Cancer
- Interventions
- Biological: High-dose interleukin-2Dietary Supplement: genistein
- Registration Number
- NCT00276835
- Lead Sponsor
- Northwestern University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Genistein and Interleukin-2 High-dose interleukin-2 - Genistein and Interleukin-2 genistein -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Circulating plasma levels of TGF-beta Prior to and at end of treatment
Trial Locations
- Locations (1)
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States