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

NCT ID: NCT00276835

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2014-01-31

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.

Conditions

Kidney Cancer; Melanoma (Skin)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genistein and Interleukin-2

Group Type: EXPERIMENTAL

High-dose interleukin-2

Intervention Type: BIOLOGICAL

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)

genistein

Intervention Type: DIETARY_SUPPLEMENT

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)

Interventions

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)

Intervention Type: BIOLOGICAL

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)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

IL-2; Aldesleukin; Proleukin; isoflavone

Eligibility Criteria

Exclusion Criteria

• Adequate pulmonary reserve

• FEV_1 > 75% of predicted
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Negative pregnancy test
• No known HIV-positive patients
• No evidence of active infection requiring antibiotic therapy
• No contraindication to treatment with pressor agents
• No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study
• No history of another malignancy other than basal cell skin cancer within 5 years

PRIOR CONCURRENT THERAPY:

• Recovered from all toxic effects of prior therapy
• No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment
• No systemic corticosteroids in the 4 weeks prior to treatment
• No previous investigational agent within 4 weeks prior to the start of the study
• No prior interleukin-2 therapy
• No organ allografts allowed
• No concurrent radiotherapy, chemotherapy, or immunotherapy
• No concurrent corticosteroids
• No concurrent chronic medication for asthma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Kuzel

Timothy Kuzel, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy M. Kuzel, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-04V1

Identifier Type: -

Identifier Source: secondary_id

CHIR-NU-04V1

Identifier Type: -

Identifier Source: secondary_id

NU-IRB-0310-083

Identifier Type: -

Identifier Source: secondary_id

NU 04V1

Identifier Type: -

Identifier Source: org_study_id