Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
I. Determine the pharmacokinetics and efficacy of continuous intraventricular methotrexate
infusion in the treatment of leptomeningeal disease.
I. Describe the dose limiting toxicities. II. Describe the pharmacodynamics of continuously
delivered intraventricular methotrexate.
III. Assess for response.
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.
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
Mike Chen, MD
City of Hope Medical Center
United States: Institutional Review Board