Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014521
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2001-04-10
Brief Title:
Karenitecin in Treating Patients With Recurrent Malignant Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2005-02
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 karenitecin in treating patients who have recurrent malignant glioma
PURPOSE Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
Determine the pharmacokinetics of this drug in these patients
Assess the preliminary evidence of therapeutic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex yes vs no
Patients receive karenitecin IV over 60 minutes on days 1-5 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose MTD is determined The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33
Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 3-24 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
Determine the pharmacokinetics of this drug in these patients
Assess the preliminary evidence of therapeutic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex yes vs no
Patients receive karenitecin IV over 60 minutes on days 1-5 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose MTD is determined The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33
Patients are followed every 2 months
PROJECTED ACCRUAL Approximately 3-24 patients will be accrued for this study within 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 |
|---|---|---|---|
| JHOC-NABTT-2006 | None | None | None |
| NABTT-2006 | None | None | None |