High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer
High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
 development or recurrence of cancer. The use of high-dose multivitamins may be an effective
 way to prevent the recurrence of early stage bladder cancer. It is not yet known whether
 high-dose vitamins are more effective than no further therapy in decreasing the risk of
 early-stage bladder cancer.

 PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose
 multivitamins with a placebo in preventing the recurrence of cancer in patients with early
 stage bladder cancer.
OBJECTIVE: I. Determine whether high dose multivitamins have chemopreventive efficacy beyond
 standard therapy in reducing the risk of recurrence in patients with resected stage 0 and I
 (Ta, T1, and Tis) transitional cell carcinoma of the bladder.

 OUTLINE: This is a randomized, double blind study. Patients are randomized to receive
 multivitamins or placebo orally once daily for 3 years. Patients are followed every 3 months
 for 2 years, then every 6 months for 1 year, and then annually thereafter.
DISEASE CHARACTERISTICS: Histologically confirmed stage 0 and I (Ta, T1 or Tis) resected
 transitional cell carcinoma of the bladder No advanced disease or muscle invasion No
 history of transitional cell carcinoma of the prostate

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
 expectancy: Greater than 3 years Hematopoietic: WBC at least 3500/mm3 Platelet count at
 least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times
 upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no
 greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not
 pregnant or nursing Fertile patients must use effective contraception At least 5 years
 since prior malignancy except nonmetastatic squamous cell or basal cell carcinoma of the
 skin No history of drug interactions which could affect therapy No immunodeficiency

 PRIOR CONCURRENT THERAPY: Biologic therapy: Prior intravesical BCG required (if T1 or Tis
 pathology and negative cytology PAB) Chemotherapy: Not specified Endocrine therapy: Not
 specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: Not specified Other:
 Intravesical therapy within 30 days allowed At least 30 days since greater than 2
 multivitamins daily