Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012038
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-03-03
Brief Title:
Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial Of MGI114 For Treatment Of Patients With Recurrent Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2003-09
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of irofulven in treating patients who have progressive or recurrent astrocytoma oligodendroglioma or glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of irofulven in treating patients who have progressive or recurrent astrocytoma oligodendroglioma or glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of irofulven alone or combined with anticonvulsants known to be metabolized by cytochrome P450 in patients with progressive or recurrent high-grade anaplastic astrocytoma anaplastic oligodendroglioma or glioblastoma multiforme
Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients
Determine the response rate of patients treated with this drug administered at the MTD
Determine the duration of progression-free survival and overall survival of patients treated with this drug
Determine the toxic effects of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent use of anticonvulsant drugs that induce cytochrome P450 yes vs no drugs or modest-induction drugs
Patients receive irofulven IV over 30 minutes on days 1-4 or 1-5 depending on dose-escalation level Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of irofulven 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 Once the MTD is determined additional patients are accrued to receive treatment with irofulven at the recommended phase II dose
Patients are followed at 1 week and then every 2 months thereafter
PROJECTED ACCRUAL Approximately 18 patients 9 per stratum will be accrued for the phase I portion of the study Approximately 17-35 patients will be accrued for the phase II portion of the study within 6-12 months
Determine the maximum tolerated dose MTD of irofulven alone or combined with anticonvulsants known to be metabolized by cytochrome P450 in patients with progressive or recurrent high-grade anaplastic astrocytoma anaplastic oligodendroglioma or glioblastoma multiforme
Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients
Determine the response rate of patients treated with this drug administered at the MTD
Determine the duration of progression-free survival and overall survival of patients treated with this drug
Determine the toxic effects of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent use of anticonvulsant drugs that induce cytochrome P450 yes vs no drugs or modest-induction drugs
Patients receive irofulven IV over 30 minutes on days 1-4 or 1-5 depending on dose-escalation level Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients per stratum receive escalating doses of irofulven 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 Once the MTD is determined additional patients are accrued to receive treatment with irofulven at the recommended phase II dose
Patients are followed at 1 week and then every 2 months thereafter
PROJECTED ACCRUAL Approximately 18 patients 9 per stratum will be accrued for the phase I portion of the study Approximately 17-35 patients will be accrued for the phase II portion of the study within 6-12 months
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-2005 | None | None | None |
| NABTT-2005 | None | None | None |