Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer
Condition: 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
MeSH terms: Urinary Bladder Neoplasms
Intervention: Genistein; Laboratory Biomarker Analysis; Pharmacological Study; Placebo Administration; Therapeutic Conventional Surgery
Intervention description: Given orally; Correlative studies; Correlative studies; Given orally; Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Intervention MeSH terms: Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants eligible for this study will have been evaluated by diagnostic office
             cystoscopy and found to have a bladder tumor; enrollment (signing of the consent form)
             must be within 60 days of pre-study cystoscopy demonstrating bladder tumor; the
             participant should have no evidence of distant metastasis and the primary tumor may
             represent either an initial diagnosis or recurrent disease of any clinical stage.
             Study participants must also be candidates for either subsequent
             cystoscopy/transurethral resection of bladder tumor (TURBT) or complete or partical
             cystectomy; histologic diagnosis is not required for enrollment; pre-enrollment
             diagnostic cystoscopy must be at least 45 days after treatment of the bladder with
             other agents such as BCG (participants with recurrent disease)

          -  ECOG performance status 0 or 1

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation

          -  Ability to understand and the willingness to sign a written informed consent document

          -  WBC >= 3000/mm^3

          -  Platelets >= 100,000mm^3

          -  Hemoglobin >= 10 g/dL

          -  Bilirubin =< 1.4 mg/dl

          -  AST =< 3x normal

          -  Creatinine =< 2.0mg/dl

          -  Serum calcium =< 10.2 mg/dl,

          -  Amylase =< 3 x normal

          -  Na >= 125 and =< 155 mmol/L

          -  K >= 3.2 and =< 6 mmol/L

          -  Cl >= 85 and =< 114 mmol/L

          -  CO2 >= 11 mEQ/dL

          -  TSH within 1.3 x the upper range of normal and normal T4

          -  Females of child-bearing potential must have a negative pregnancy test; patients who
             have had a bilateral oophorectomy, hysterectomy, are greater than 1 year since their
             last menses, or are greater than 51 years of age are not considered to be of
             child-baring potential

          -  Participants must agree to stop soy supplements before enrolling in the study

          -  Patients must agree to stop taking NSAIDS before enrolling in the study; patients may,
             however, take cardioprotective doses of aspirin equal to or less than 81mg per day

        Exclusion Criteria:

          -  Participant may not have received other treatment for bladder cancer between the
             pre-enrollment cystoscopy and subsequent surgery

          -  Participants may not be receiving any other investigational agents

          -  Participant may not have received prior pelvic irradiation for any reason

          -  Participant may not be receiving concurrent systemic cancer treatment for other
             cancers

          -  Participant may not be taking concurrent soy supplements while on the study medication

          -  Participant may not be taking concurrent NSAIDS (aspirin doses of =< 81 mg acceptable)
             while on the study medication

          -  Participant may not be taking thyroid medications

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to genistein, soy isoflavones or other allergies to soy-based products
             will render a participant ineligible

          -  Uncontrolled concurrent illness will render a participant ineligible including,
             ongoing or active infection, symptomatic congestive heart failure, unstable angina
             pectoris, unregulated cardiac arrhythmia, or psychiatric illness/social situations
             that would limit compliance with study requirements

          -  Women may not be pregnant or lactating; the effects of G-2535 on the developing human
             fetus at the recommended therapeutic dose are unknown; for this reason women of
             childbearing potential and men must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of study participation; should a woman become pregnant or suspect she is pregnant
             while participating in this study, she should inform her treating physician
             immediately