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Genistein in Reducing the Toxicity and Improving the Efficacy of Bacillus Calmette Guerin Intravesical Therapy in Patients with Bladder Cancer

Trial Status: Active

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.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Omer Kucuk
Phone: 404-778-1900
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Omer Kucuk
Phone: 404-778-1900
Emory University Hospital Midtown
Status: APPROVED
Contact: Omer Kucuk

PRIMARY OBJECTIVE:

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.

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Omer Kucuk

  • Primary ID EU2010-11
  • Secondary IDs NCI-2014-02088, IRB00050273
  • Clinicaltrials.gov ID NCT01489813