Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463008
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2007-04-18
Brief Title:
Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter
Status:
COMPLETED
Status Verified Date:
2008-01
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 Collecting fluid from a brain tumor using a small catheter may help doctors learn how much methotrexate gets into the tumor to kill the tumor cells It may also help doctors learn how methotrexate works in the brain and in the rest of the body
PURPOSE This clinical trial is studying how much methotrexate gets into the brain tumor by collecting fluid directly from the tumor through a small catheter in patients undergoing stereotactic biopsy for recurrent high-grade glioma
PURPOSE This clinical trial is studying how much methotrexate gets into the brain tumor by collecting fluid directly from the tumor through a small catheter in patients undergoing stereotactic biopsy for recurrent high-grade glioma
Detailed Description:
OBJECTIVES
Determine the feasibility of using microdialysis to study distribution of systemically administered methotrexate in the interstitial fluid within a tumor in patients undergoing stereotactic biopsy for recurrent high-grade gliomas
Determine the systemic and intratumoral pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients have an intratumoral microdialysis catheter placed while undergoing stereotactic biopsy Between 18-32 hours after placement of catheter patients receive methotrexate IV over 4 hours Microdialysis perfusate and blood specimens are collected before during and for 24 hours after methotrexate administration
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 6 months
Determine the feasibility of using microdialysis to study distribution of systemically administered methotrexate in the interstitial fluid within a tumor in patients undergoing stereotactic biopsy for recurrent high-grade gliomas
Determine the systemic and intratumoral pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients have an intratumoral microdialysis catheter placed while undergoing stereotactic biopsy Between 18-32 hours after placement of catheter patients receive methotrexate IV over 4 hours Microdialysis perfusate and blood specimens are collected before during and for 24 hours after methotrexate administration
Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 6 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-0302 | None | None | None |
| NABTT-0302 | None | None | None |