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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Timothy Kuzel, Northwestern University
ClinicalTrials.gov Identifier:
NCT00276835
First received: January 12, 2006
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Kidney Cancer
Melanoma (Skin)
Biological: High-dose interleukin-2
Dietary Supplement: genistein
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Circulating plasma levels of TGF-beta [ Time Frame: Prior to and at end of treatment ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: November 2005
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276835

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Timothy Kuzel, Timothy Kuzel, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00276835     History of Changes
Other Study ID Numbers: NU 04V1, NU-04V1, CHIR-NU-04V1, NU-IRB-0310-083
Study First Received: January 12, 2006
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
Carcinoma, Renal Cell
Kidney Neoplasms
Melanoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2
Genistein
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phytoestrogens

ClinicalTrials.gov processed this record on April 22, 2014