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Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy

Status
Active
Cancer Type
Bladder Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT01489813
Protocol IDs
EU2010-11 (primary)
NCI-2014-02088
IRB00050273
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This randomized phase II trial studies how well genistein works in reducing the toxicity and improving the efficacy of Bacillus Calmette Guerin intravesical (within the bladder) therapy in patients with bladder cancer. Genistein may reduce adverse urinary tract symptoms due to inflammation from intravesical therapy and improve the quality of life of patients with bladder cancer. Genistein may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVES:
I. The change in severity of urinary symptoms over time as determined by the International Prognostic Scoring System (IPSS) questionnaire score, specifically comparing the symptoms at the 1st Bacillus Calmette Guerin (BCG) treatment (baseline) to the symptoms at the 6th week of treatment.

SECONDARY OBJECTIVES:
I. The presence of cancer and the rate of recurrence as determined by the 10-week biopsy or subsequent standard follow-up visits.
II. The total dose of intravesical therapy administered over the 6 weeks of treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive placebo orally (PO) three times daily (TID) for 10 weeks.

ARM II: Patients receive genistein PO TID for 10 weeks.

After completion of study treatment, patients are followed up for 1 month.
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