Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT03154996
PHASE1

Chronic Convection Enhanced Delivery of Topotecan

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

The primary goal of this study is to establish, for the first time, safety of prolonged intracerebral convection enhanced delivery of chemotherapy in patients with recurrent high grade glioma (HGG). Secondary objectives will include determination of topotecan (TPT) distribution and radiographic tumor response with prolonged continuous intracerebral convection-enhanced delivery (CED).

Official title: Chronic Convection Enhanced Delivery of Topotecan for Recurrent High Grade Gliomas

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2018-01-18

Completion Date

2021-08-20

Last Updated

2026-04-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Topotecan

Topotecan is a chemotherapeutic agent that is a topoisomerase inhibitor. TPT is administered through an externalized catheter and external microinfusion pump. Dose: 146 micrometers (uM)

DRUG

Gadolinium

Gadolinium is a widely available MRI contrast agent that is used routinely in clinical practice via IV administration, especially for imaging of intracranial tumors.

DEVICE

Synchromed II infusion pumps

Implanted subcutaneously to facilitate chronic infusion.

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States