Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006476
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-11-06
Brief Title:
Suramin in Treating Patients With Recurrent Bladder Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 tumors 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
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 tumors 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-954 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068303 | REGISTRY | None | None |