Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022360
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-08-10
Brief Title:
Taurolidine in Treating Patients With Recurrent or Progressive Glioma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2 Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent or progressive glioma
PURPOSE Phase I trial to study the effectiveness of taurolidine in treating patients who have recurrent or progressive glioma
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of taurolidine in patients with recurrent or progressive high-grade glioma II Determine the safety and toxicity of this drug in these patients III Determine the pharmacokinetics of this drug in these patients IV Determine the response in patients treated with this drug
OUTLINE This is a dose-escalation study Patients receive taurolidine IV over 1-4 hours on days 1-5 8-12 and 15-19 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 4-24 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive taurolidine IV over 1-4 hours on days 1-5 8-12 and 15-19 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 1-6 patients receive escalating doses of taurolidine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 4-24 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-2000 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068808 | REGISTRY | None | None |
| WALLACE-393 | None | None | None |