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.

Condition	Treatment or Intervention	Phase
transitional cell carcinoma of the bladder stage I bladder cancer stage 0 bladder cancer prevention of bladder cancer	Drug: multivitamins	Phase III

Further Study Details: 

OBJECTIVES: 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.

PROTOCOL 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.

PROJECTED ACCRUAL: A total of 360 patients (180/arm) will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CentraCare Clinic, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
North Dakota
      Altru Health Systems, Grand Forks,  North Dakota,  58201,  United States
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Michael L. Blute,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000066702; NCCTG-979252; NCI-P98-0138
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003623
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08