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

Primary Purpose

Kidney Cancer, Melanoma (Skin)

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
High-dose interleukin-2
genistein
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Genistein and Interleukin-2

Arm Description

Outcomes

Primary Outcome Measures

Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)

Secondary Outcome Measures

Circulating plasma levels of TGF-beta

Full Information

First Posted
January 12, 2006
Last Updated
April 8, 2015
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00276835
Brief Title
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Melanoma (Skin)
Keywords
recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genistein and Interleukin-2
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
High-dose interleukin-2
Other Intervention Name(s)
IL-2, Aldesleukin, Proleukin
Intervention Description
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
Dietary Supplement
Intervention Name(s)
genistein
Other Intervention Name(s)
isoflavone
Intervention Description
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)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Circulating plasma levels of TGF-beta
Time Frame
Prior to and at end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M. Kuzel, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States

12. IPD Sharing Statement

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

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