Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064363
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2003-07-08
Brief Title:
Talampanel in Treating Patients With Recurrent High-Grade Glioma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as talampanel use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well talampanel works in treating patients with recurrent progressive high-grade glioma
PURPOSE This phase II trial is studying how well talampanel works in treating patients with recurrent progressive high-grade glioma
Detailed Description:
OBJECTIVES
Determine the efficacy of talampanel in terms of 6-month progression-free survival in patients with recurrent high-grade gliomas
Determine preliminarily the toxic effects of this drug in these patients
Determine preliminarily the quality of life of patients treated with this drug
Determine the pharmacokinetics of this drug in patients who are and who are not receiving enzyme-inducing antiepileptic drugs
OUTLINE Patients are stratified according to type of glioma anaplastic astrocytoma vs glioblastoma multiforme Patients in each stratum are assigned to 1 of 3 treatment groups according to concurrent enzyme-inducing antiepileptic drug use yes no or valproic acid
Patients in each group receive different doses of oral talampanel 3 times daily on days 1-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 3 weeks during the first course every 6 weeks before all subsequent courses and then within 2 weeks of study completion
Patients are followed within 2 weeks
PROJECTED ACCRUAL A total of 91 patients 50 with anaplastic astrocytoma and 41 with glioblastoma multiforme will be accrued for this study within 1 year
Determine the efficacy of talampanel in terms of 6-month progression-free survival in patients with recurrent high-grade gliomas
Determine preliminarily the toxic effects of this drug in these patients
Determine preliminarily the quality of life of patients treated with this drug
Determine the pharmacokinetics of this drug in patients who are and who are not receiving enzyme-inducing antiepileptic drugs
OUTLINE Patients are stratified according to type of glioma anaplastic astrocytoma vs glioblastoma multiforme Patients in each stratum are assigned to 1 of 3 treatment groups according to concurrent enzyme-inducing antiepileptic drug use yes no or valproic acid
Patients in each group receive different doses of oral talampanel 3 times daily on days 1-42 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 3 weeks during the first course every 6 weeks before all subsequent courses and then within 2 weeks of study completion
Patients are followed within 2 weeks
PROJECTED ACCRUAL A total of 91 patients 50 with anaplastic astrocytoma and 41 with glioblastoma multiforme will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000315425 | None | None | None |
| 03-C-0207 | None | None | None |