Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma

Malignant Glioma Clinical Trial

Official title: A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Requiring Stereotactic Biopsy

Status Completed

Clinical Trial Summary

Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan directly into participants' brain tumors. One purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan directly into brain tumors. This study will also evaluate different doses of topotecan that can be delivered to a participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also examine how their tumor responds to treatment with topotecan.

Clinical Trial Description

This study will look at the way topotecan is injected into participant's tumor. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the tumor with an MRI machine. This will allow the investigators to see where in the tumor the topotecan has been injected. Issues related to patient selection, coordination with other therapeutic and palliative clinical options, and patient quality of life impact will be studied. Except for the infusion of topotecan and gadolinium DTPA into the tumor, and MRI imaging of the infusion process, all procedures and treatments participants will experience during the care of their brain tumor are non-investigational; the types of medical treatments, procedures, and tests they experience will be Standard of Care for patients with brain tumors.

Primary Objectives:

• To investigate by MR imaging the spatial and temporal distribution of topotecan in tumor and tumor-infiltrated brain administered by convection-enhanced delivery (CED) in patients with recurrent/progressive WHO grade III or IV (high grade) glioma (HGG) who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy

• To investigate by MR imaging the influence of the rate and topotecan concentration, on the spatial and temporal distribution of topotecan administered by CED in patients with recurrent/progressive HGG

• To evaluate the spatial and temporal distribution of topotecan, by MR imaging, when delivered into enhancing tumor tissue versus non-enhancing tumor tissue (as defined on pre-operative conventional MRI imaging with and without intravenous gadolinium)

Secondary Objectives:

• To investigate the extent to which backflow may be observed on MRI during CED-mediated delivery of topotecan

• To assess the safety, tolerability and toxicity profile of topotecan administered by CED using different doses and infusion rates

• To observe evidence of activity of single-agent topotecan administered by CED to patients with recurrent/progressive HGG who have failed standard therapy comprising surgical biopsy and/or resection and adjuvant chemotherapy and radiotherapy ;

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma
• WHO Grade III or IV Recurrent Glioma

• NCT number: NCT02278510
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Completed
• Phase: Early Phase 1
• Start date: December 9, 2014
• Completion date: November 10, 2015