Spots Global Cancer Trial Database for Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
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Trial Identification
Brief Title: Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease
Official Title: Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease
Study ID: NCT01438021
Conditions
Study Description
Brief Summary: This pilot clinical trial studies continuous intraventricular methotrexate in treating patients with leptomeningeal disease. Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the ventricles may be an effective treatment for patients with leptomeningeal disease
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Mike Chen, MD
Affiliation: City of Hope Medical Center
Role: PRINCIPAL_INVESTIGATOR
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