NCT00276835

Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer
• Melanoma (Skin)

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-07-01
• Completion: 2014-01-01
• First posted: 2006-01-13
• Last updated: 2015-04-10

Locations

1 site across 1 country: United States