NCT00463008

Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma

A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: New Approaches to Brain Tumor Therapy Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	methotrexate
OTHER	pharmacological study

Timeline

• Start date: 2004-05-01
• Completion: 2007-04-01
• First posted: 2007-04-19
• Last updated: 2013-06-24