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Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

NCT02500459 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-03-01

No results posted yet for this study

Summary

Topotecan is an FDA-approved drug when given by intravenous infection. The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into the part of the brain where the tumor has spread, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into tumor-infiltrated brain. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into tumor-infiltrated brain. This study will also examine how tumors responds to treatment with topotecan. This study will also look at the way topotecan is injected into tumors-infiltrated brain. A small amount of contrast dye (called gadolinium DTPA) will be added to topotecan before it is injected. Pictures will be taken of the brain with an MRI machine. This will allow the investigators to see where in the tumor-infiltrated brain the topotecan has been injected. This study will collect medical information before, during, and after treatment in order to better understand hot to make this type of procedure accessible to patients.

Conditions

Interventions

DRUG

topotecan

intraparenchymally-administered topotecan will use the Cleveland Multiport Catheter to directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). This drug is already FDA approved to be administered intravenously.

DEVICE

Cleveland Multiport Catheter

The Cleveland Multiport Catheter will directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). Standard treatment is to adminsiter the drug intravenously.

Sponsors & Collaborators

  • Infuseon Therapeutics, Inc.

    collaborator INDUSTRY

  • Michael Vogelbaum, MD, PhD

    lead OTHER

Principal Investigators

  • Michael A Vogelbaum, MD, PhD · Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-06
Primary Completion
2018-11-19
Completion
2018-11-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500459 on ClinicalTrials.gov