High-Dose Multivitamins Compared to 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