NCT01438021

Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

Characterization of the Pharmacokinetics and Efficacy of Intraventricular Methotrexate Continuously Delivered Via a Mini Pump for Treatment of Leptomeningeal Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leptomeningeal Metastases

Interventions

Type	Name	Description
OTHER	pharmacological study	Correlative studies
DRUG	methotrexate	Given intraventricularly

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-11-01
• First posted: 2011-09-21
• Last updated: 2012-11-09