Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
18 Years and older, Male and Female
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.
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.
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.