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
- 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
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Primary Purpose: Treatment
Jeffrey M. Ignatoff, MD
NorthShore University HealthSystem Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Veterans Affairs Medical Center - East Orange||East Orange, New Jersey 07018-1095|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|Veterans Affairs Medical Center - Madison||Madison, Wisconsin 53705|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)||Milwaukee, Wisconsin 53295|
|CCOP - Green Bay||Green Bay, Wisconsin 54301|