Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Closed 18 and over NCI NCCTG-979252 NCI-P98-0138, NCT00003623

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.

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Michael Blute, MD, Protocol chair		Ph: 507-284-3982 Email: blute.michael@mayo.edu

Registry Information
Official Title		Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder
Trial Start Date		1999-10-29
Registered in ClinicalTrials.gov		NCT00003623
Date Submitted to PDQ		1998-10-08
Information Last Verified		2007-05-31
NCI Grant/Contract Number		CA31946