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Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

Official Title: Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin

Study ID: NCT00003129

Conditions

Bladder Cancer

Interventions

valrubicin

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.

Detailed Description: OBJECTIVES: * Determine the recurrence rate and disease free survival in patients with recurrent or refractory papillary transitional cell carcinoma of the bladder with or without carcinoma in situ of the bladder treated with intravesical AD 32. * Evaluate the safety of administering this drug in these patients. * Determine the effectiveness of this drug, in terms of recurrence rates and disease free survival, in these patients. OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1). Patients receive intravesical AD 32 once a week for 6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania, United States

CCOP - Green Bay, Green Bay, Wisconsin, United States

Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States

Contact Details

Name: Jeffrey M. Ignatoff, MD

Affiliation: NorthShore University HealthSystem

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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