Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045708
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2002-09-06
Brief Title:
A Phase III Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of BMS-247550 for Treatment of Patients With Recurrent High-grade Gliomas
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die This phase III trial is studying the side effects and best dose of ixabepilone and how well it works in treating patients with recurrent glioma
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of BMS-247550 when administered to adults with recurrent malignant gliomas receiving Group A or not receiving Group B anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
II To describe the pharmacokinetics of this route of administration measuring BMS-247550 and determine the effects of hepatic enzyme inducing drugs such as anticonvulsants on the pharmacokinetics
III To determine the response rate of adult patients with recurrent glioma to BMS-247550 administered at the MTD
IV To describe the toxicity associated with this regimen in adult patients with recurrent malignant gliomas
SECONDARY OBJECTIVES
I To determine the percent of patients with 6 month progression free survival duration of progression free survival and survival associated with this therapy in adult patients with recurrent malignant gliomas
OUTLINE This is a phase I dose-escalation multicenter study followed by a phase II safety and efficacy multicenter study For phase I only patients are stratified according to cytochrome P450-inducing anticonvulsant use yes vs no
Phase I Patients receive ixabepilone IV over 1 hour on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity
Phase II Once the MTD is determined additional patients receive ixabepilone as above at the MTD
Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 10-15 patients will be accrued for the phase I portion of this study A total of 22-33 patients will be accrued for the phase II portion of this study within 4-6 months
I To determine the maximum tolerated dose of BMS-247550 when administered to adults with recurrent malignant gliomas receiving Group A or not receiving Group B anticonvulsants known to be metabolized by the P450 hepatic enzyme complex
II To describe the pharmacokinetics of this route of administration measuring BMS-247550 and determine the effects of hepatic enzyme inducing drugs such as anticonvulsants on the pharmacokinetics
III To determine the response rate of adult patients with recurrent glioma to BMS-247550 administered at the MTD
IV To describe the toxicity associated with this regimen in adult patients with recurrent malignant gliomas
SECONDARY OBJECTIVES
I To determine the percent of patients with 6 month progression free survival duration of progression free survival and survival associated with this therapy in adult patients with recurrent malignant gliomas
OUTLINE This is a phase I dose-escalation multicenter study followed by a phase II safety and efficacy multicenter study For phase I only patients are stratified according to cytochrome P450-inducing anticonvulsant use yes vs no
Phase I Patients receive ixabepilone IV over 1 hour on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity
Phase II Once the MTD is determined additional patients receive ixabepilone as above at the MTD
Patients are followed every 2 months
PROJECTED ACCRUAL A minimum of 10-15 patients will be accrued for the phase I portion of this study A total of 22-33 patients will be accrued for the phase II portion of this study within 4-6 months
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 |
|---|---|---|---|
| U01CA062475 | NIH | None | httpsreporternihgovquickSearchU01CA062475 |
| NABTT 2111 | None | None | None |
| CDR257118 | None | None | None |