Research

Neoplastic Meningitis Treatment with Topotecan - Phase I

Pharmacokinetic Optimal Dosing Study of Intrathecal Topotecan for Children with Neoplastic Meningitis

Protocol Description

This Pediatric Brain Tumor Consortium study is being conducted to test the experimental drug topotecan in the hopes of finding a new treatment that will fight neoplastic meningitis, for which there is no known curative therapy. When given intravenously, topotecan has been shown to have anti-tumor abilities against a wide variety of cancers in children and adults. Through injection directly into the spinal fluid, the goal is to find the optimal dose, the effects and the benefits of the method of treatment.

Eligibility Criteria

The group-wide study is currently accepting male and female patients through the age of 21, who satisfy study criteria, and have been diagnosed with neoplastic meningitis.
Boys: 3 to 21 years
Girls: 3 to 21 years

Requirements
Participants will receive an Ommaya reservoir, a surgically implanted catheter through which topotecan will be given directly into the cerebrospinal fluid. Throughout the length of the study, blood draws, physical exams and other tests will be given to monitor the tumor status.
Visits: Number varies depending on participant’s response to chemotherapy.
Duration: Depending on outcomes, treatment may extend 14 months with patient’s health monitored after treatment ends.

Status: Open For Enrollment

Source of Support
National Cancer Institute
Pediatric Brain Tumor Consortium (Study PBTC-019 v. 2.0)

Additional Resources
Study Description at National Institutes of Health