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Brief Title: Arsenic Trioxide in Treating Patients With Urothelial Cancer
Official Title: A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
Study ID: NCT00009867
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer and Leukemia Group B, Chicago, Illinois, United States
Name: Dean Bajorin
Affiliation: Cancer and Leukemia Group B
Role: PRINCIPAL_INVESTIGATOR