Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004147
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-12-10
Brief Title:
COL-3 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 Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma
Status:
COMPLETED
Status Verified Date:
2003-05
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 COL-3 may stop the growth of brain tumors by stopping blood flow to the tumor
PURPOSE Phase III trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy
PURPOSE Phase III trial to study the effectiveness of COL-3 in treating patients who have progressive or recurrent brain tumors following radiation therapy or chemotherapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose dose limiting toxicity and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma anaplastic oligodendroglioma or glioblastoma multiforme
Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs such as anticonvulsants on the pharmacokinetics
Determine the response rate disease free survival and survival in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study of COL-3 Patients are stratified by anticonvulsant anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant
Phase I Patients receive oral COL-3 daily Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive oral COL-3 daily at the MTD from the phase I portion of this study
Patients are followed every 2 months until death
PROJECTED ACCRUAL A total of 15-18 patients will be accrued for phase I of the study and a total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per month
Determine the maximum tolerated dose dose limiting toxicity and safety profile of oral COL-3 alone or when combined with anticonvulsants known to be metabolized by CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma anaplastic oligodendroglioma or glioblastoma multiforme
Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and determine the effects of hepatic enzyme inducing drugs such as anticonvulsants on the pharmacokinetics
Determine the response rate disease free survival and survival in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study of COL-3 Patients are stratified by anticonvulsant anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause modest or no induction of CYP450 or no anticonvulsant
Phase I Patients receive oral COL-3 daily Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Phase II Patients receive oral COL-3 daily at the MTD from the phase I portion of this study
Patients are followed every 2 months until death
PROJECTED ACCRUAL A total of 15-18 patients will be accrued for phase I of the study and a total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per month
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-9809 | None | None | None |
| NABTT-9809 | None | None | None |