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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276835
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 10, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Timothy Kuzel, 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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Melanoma (Skin) Biological: High-dose interleukin-2 Dietary Supplement: genistein Early Phase 1

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2014

Arm Intervention/treatment
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:
  • IL-2
  • Aldesleukin
  • Proleukin

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Circulating plasma levels of TGF-beta [ Time Frame: Prior to and at end of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Documented histologically confirmed malignant melanoma or renal clear cell carcinoma

    • Metastatic disease
  • At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques OR > 10 mm with spiral CT scan

    • If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
    • Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
    • The following are considered non-measurable lesions:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Cystic lesions
      • Abdominal masses that are not confirmed and followed by imaging techniques
  • No CNS metastases by CT scan or MRI


  • ECOG performance status < 2
  • Life expectancy ≥ 4 months
  • Serum creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min
  • Bilirubin normal
  • Platelets > 100,000/mm³
  • WBC > 3,500/mm³
  • No evidence of congestive heart failure
  • No symptom of coronary artery disease
  • No serious cardiac arrhythmias
  • A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276835

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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
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Responsible Party: Timothy Kuzel, Timothy Kuzel, MD, Northwestern University Identifier: NCT00276835    
Other Study ID Numbers: NU 04V1
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Timothy Kuzel, Northwestern University:
recurrent renal cell cancer
clear cell renal cell carcinoma
stage IV renal cell cancer
recurrent melanoma
stage IV melanoma
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents