Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
PRIMARY OBJECTIVES:
I. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate
infusion in the treatment of leptomeningeal disease.
SECONDARY OBJECTIVES:
I. Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously
delivered intraventricular methotrexate.
III. Assess for response.
OUTLINE:
Patients receive intraventricular methotrexate continuously on days 1-14. Treatment
continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of continuously delivered intraventricular methotrexate
The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
Day 3 after start of treatment
No
Mike Chen, MD
Principal Investigator
City of Hope Medical Center
United States: Institutional Review Board
09201
NCT01438021
September 2012
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