Genistein in Reducing the Toxicity and Improving the Efficacy of Bacillus Calmette Guerin Intravesical Therapy in Patients with Bladder Cancer
- Diagnosis of superficial bladder cancer
- Scheduled for induction BCG intravesical therapy
- Willing and able to give blood sample
- Willing and able to fill out a pill diary to ensure compliance
- Willing and able to sign informed consent * Birth control is not required for this study
- Patients who are pregnant
- Diagnosis of muscle-invasive bladder cancer
- Unwillingness to follow study protocol and compliance procedures
- Human immunodeficiency virus (HIV) positive or immunocompromised
- Receiving concurrent immunotherapy or chemotherapy
- Presence of concurrent second cancer (active, not history)
I. The change in severity of urinary symptoms over time as determined by the International Prostate Symptom Score (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.
Trial Phase Phase II
Trial Type Treatment
Emory University Hospital / Winship Cancer Institute
- Primary ID EU2010-11
- Secondary IDs NCI-2014-02088, IRB00050273
- Clinicaltrials.gov ID NCT01489813