Suramin in Treating Patients With Recurrent Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00006476|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: suramin Procedure: conventional surgery||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Official Title:||A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer|
|Study Start Date :||October 2000|
|Actual Study Completion Date :||October 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006476
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Study Chair:||Adrian L. Harris, MD||Oxford University Hospitals NHS Trust|