Suramin in Treating Patients With Recurrent Bladder Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer|
|Study Start Date:||October 2000|
|Study Completion Date:||October 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006476
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Study Chair:||Adrian L. Harris, MD||Oxford University Hospitals NHS Trust|