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

NCT00276835 | Completed Early Phase 1

• 4 other identifiers: NU 04V1NU-04V1CHIR-NU-04V1NU-IRB-0310-083
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer; Melanoma (Skin)

Keywords

recurrent renal cell cancer; clear cell renal cell carcinoma; stage IV renal cell cancer; recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

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

  Days 1, 8, 10, 15, 22, and 24 of treatment

Secondary Outcomes (1)

• Circulating plasma levels of TGF-beta

  Prior to and at end of treatment

Study Arms (1)

Genistein and Interleukin-2

EXPERIMENTAL

Biological: High-dose interleukin-2; Dietary Supplement: genistein

Interventions

High-dose interleukin-2 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)

Also known as: IL-2, Aldesleukin, Proleukin

Genistein and Interleukin-2

genistein 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)

Also known as: isoflavone

Genistein and Interleukin-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Melanoma; Carcinoma, Renal Cell

Interventions

Interleukin-2; aldesleukin; Genistein; Isoflavones

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Timothy M. Kuzel, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Timothy Kuzel, MD

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: November 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)