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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003129 |
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.
Condition | Intervention | Phase |
Bladder Cancer |
Drug: valrubicin |
Phase II |
Genetics Home Reference related topics: | bladder cancer |
MedlinePlus related topics: | Bladder Cancer Cancer |
ChemIDplus related topics: | BCG Vaccine N-Trifluoroacetyladriamycin 14-valerate |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Estimated Enrollment: | 75 |
Study Start Date: | July 1998 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent superficial bladder cancer defined as papillary transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the urinary bladder
Must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Florida | |||||
H. Lee Moffitt Cancer Center and Research Institute | |||||
Tampa, Florida, United States, 33612-9497 | |||||
United States, Illinois | |||||
CCOP - Carle Cancer Center | |||||
Urbana, Illinois, United States, 61801 | |||||
United States, New Jersey | |||||
Veterans Affairs Medical Center - East Orange | |||||
East Orange, New Jersey, United States, 07018-1095 | |||||
United States, Pennsylvania | |||||
CCOP - MainLine Health | |||||
Wynnewood, Pennsylvania, United States, 19096 | |||||
Fox Chase Cancer Center | |||||
Philadelphia, Pennsylvania, United States, 19111 | |||||
United States, Wisconsin | |||||
Veterans Affairs Medical Center - Milwaukee (Zablocki) | |||||
Milwaukee, Wisconsin, United States, 53295 | |||||
Medical College of Wisconsin | |||||
Milwaukee, Wisconsin, United States, 53226 | |||||
University of Wisconsin Comprehensive Cancer Center | |||||
Madison, Wisconsin, United States, 53792-6164 | |||||
Veterans Affairs Medical Center - Madison | |||||
Madison, Wisconsin, United States, 53705 | |||||
CCOP - Green Bay | |||||
Green Bay, Wisconsin, United States, 54301 |
Eastern Cooperative Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Jeffrey M. Ignatoff, MD | Evanston Northwestern Healthcare - Evanston Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065892, E-3897 |
First Received: | November 1, 1999 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00003129 |
Health Authority: | United States: Federal Government |
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