Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068770
Status:
TERMINATED
Last Update Posted:
2015-03-18
First Post:
2003-09-10
Brief Title:
Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
EORTC trail showed TMZ RT conferred significant survivial in this population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy
PURPOSE Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Determine the effects of hepatic enzyme-inducing drugs such as anticonvulsants on the pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme undergoing radiotherapy
Determine the effects of steroids on the pharmacokinetics of celecoxib in these patients
Secondary
Determine the safety of celecoxib in these patients
Determine the duration of survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients are assigned to 1 of 2 groups based on anticonvulsant therapy
Group A Patients treated with any of the following anticonvulsant drugs that induce hepatic metabolic enzymes
Phenytoin
Carbamazepine
Phenobarbital
Primidone
Oxcarbazepine
Group B Patients treated with any of the following anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug
Gabapentin
Lamotrigine
Valproic acid
Levetiracetam
Tiagabine
Topiramate
Zonisamide
Felbamate
Induction therapy Patients in both groups receive oral celecoxib twice daily on weeks 1-11 and undergo radiotherapy 5 days a week on weeks 2-7
Maintenance therapy Patients receive oral celecoxib twice daily Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
NOTE Patients receive only 1 dose on the first day of celecoxib administration
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 44 patients 22 per group will be accrued for this study within approximately 8 months
Primary
Determine the effects of hepatic enzyme-inducing drugs such as anticonvulsants on the pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme undergoing radiotherapy
Determine the effects of steroids on the pharmacokinetics of celecoxib in these patients
Secondary
Determine the safety of celecoxib in these patients
Determine the duration of survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients are assigned to 1 of 2 groups based on anticonvulsant therapy
Group A Patients treated with any of the following anticonvulsant drugs that induce hepatic metabolic enzymes
Phenytoin
Carbamazepine
Phenobarbital
Primidone
Oxcarbazepine
Group B Patients treated with any of the following anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drug
Gabapentin
Lamotrigine
Valproic acid
Levetiracetam
Tiagabine
Topiramate
Zonisamide
Felbamate
Induction therapy Patients in both groups receive oral celecoxib twice daily on weeks 1-11 and undergo radiotherapy 5 days a week on weeks 2-7
Maintenance therapy Patients receive oral celecoxib twice daily Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
NOTE Patients receive only 1 dose on the first day of celecoxib administration
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 44 patients 22 per group will be accrued for this study within approximately 8 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 |
|---|---|---|---|
| JHOC-NABTT-2100 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062475 |
| U01CA062475 | NIH | None | None |
| NABTT-2100 | None | None | None |