Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma
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.
Brain and Central Nervous System Tumors
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter|
- Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum [ Designated as safety issue: No ]
- Safety and efficacy of the microdialysis catheter [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Study Completion Date:||April 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463008
|Study Chair:||Jeffrey J. Olson, MD||Winship Cancer Institute of Emory University|
|Investigator:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center|