Clinical Trial: Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: City of Hope Medical Center

Current Primary Outcome:

  • Efficacy of continuously delivered intraventricular methotrexate [ Time Frame: Day 3 after start of treatment ]
    The concentration of methotrexate in the brain parenchyma will be determined with microdialysis probe placed next to the ventricle.
  • Pharmacokinetics of continuous intraventricular infusion of methotrexate [ Time Frame: Day 14 after start of treatment ]
    Determined by measuring brain interstitial levels of methotrexate using microdialysis catheters, lumbar cerebral spinal fluid (CSF) levels (a distant site) of methotrexate via a lumbar drain during the inpatients phase, ventricular CSF levels of methotrexate using the Ommaya reservoir, and systemic levels of methotrexate in the blood.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response rate of continuous intraventricular methotrexate infusion [ Time Frame: Day 42 after start of treatment ]
  • Toxicities of continuous intraventricular methotrexate infusion [ Time Frame: Day 3 after start of treatment ]
  • Pharmacodynamics of continuously delivered intraventricular methotrexate [ Time Frame: Day 42 after start of treatment ]


Original Secondary Outcome: Same as current

Information By: City of Hope Medical Center

Dates:
Date Received: September 19, 2011
Date Started: September 2012
Date Completion:
Last Updated: November 8, 2012
Last Verified: November 2012