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Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder


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.

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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Michael L. Blute, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066702

NCT ID:

NCT00003623

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • recurrent bladder cancer
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell

Name

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