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Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer

NCT00118040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-10

Study results available
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Summary

Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how genistein or placebo works in patients with bladder cancer. This randomized phase II trial is studying genistein or placebo to compare how they work in patients who are undergoing surgery for bladder cancer.

Conditions

  • Recurrent Bladder Carcinoma
  • Stage I Bladder Cancer AJCC v6 and v7
  • Stage II Bladder Cancer AJCC v6 and v7
  • Stage III Bladder Cancer AJCC v6 and v7

Interventions

DRUG

Genistein

Given orally

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

OTHER

Placebo Administration

Given orally

PROCEDURE

Therapeutic Conventional Surgery

Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Howard H Bailey · University of Wisconsin Chemoprevention Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-24
Primary Completion
2010-08-15
Completion
2010-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118040 on ClinicalTrials.gov