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Brief Title: Suramin in Treating Patients With Recurrent Bladder Cancer
Official Title: A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
Study ID: NCT00006476
Brief Summary: RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer. * Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients. OUTLINE: This is a dose escalation study. At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity. Patients are followed at 2-4 weeks. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Oxford Radcliffe Hospital, Oxford, England, United Kingdom
Name: Adrian L. Harris, MD
Affiliation: Oxford University Hospitals NHS Trust
Role: STUDY_CHAIR