A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter
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.
Interventional
Allocation: Non-Randomized, Primary Purpose: Treatment
Comparison of methotrexate levels in the brain extracelluar fluid vs in the serum
No
Jeffrey J. Olson, MD
Study Chair
Winship Cancer Institute of Emory University
United States: Federal Government
CDR0000346432
NCT00463008
May 2004
April 2007
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