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

April 8, 2015 updated by: Timothy Kuzel, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Proleukin
  • Aldesleukin
  • IL-2
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 Names:
  • isoflavone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days 1, 8, 10, 15, 22, and 24 of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Circulating plasma levels of TGF-beta
Time Frame: Prior to and at end of treatment
Prior to and at end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 04V1
  • NU-04V1
  • CHIR-NU-04V1
  • NU-IRB-0310-083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Clinical Trials on High-dose interleukin-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe