Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder
18 Years
N/A
Both
Bladder Cancer
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 |
