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Spots Global Cancer Trial Database for Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma

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Trial Identification

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

Official Title: A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter

Study ID: NCT00463008

Study Description

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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Jeffrey J. Olson, MD

Affiliation: Emory University

Role: STUDY_CHAIR

Name: Stuart A. Grossman, MD

Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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