Transitional Cell Carcinoma of the Bladder Clinical Trial
Official title:
A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.
PRIMARY OBJECTIVES:
I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial
carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial
cancer.
OUTLINE:
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28
days for a minimum of 2 courses in the absence of disease progression or unacceptable
toxicity. Patients who achieve complete response receive 2 additional courses.
Patients are followed every 2 months for 1 year after registration and then every 6 months
for 1 year or until disease progression or relapse.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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