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Intratumorally-Administered Topotecan Using CED in High Grade Glioma Undergoing Stereotactic Biopsy

NCT03193463 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2019-03-01

No results posted yet for this study

Summary

The purpose of this study is to determine if treatment with topotecan by an alternative method, direct delivery into brain tumors, is safe and well tolerated. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan into your brain tumor. A second purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan into your brain tumor.

This study will also determine the best dose of topotecan to deliver to your tumor with use of the Cleveland Multiport Catheter and will also examine how your tumor responds to treatment with topotecan.

Conditions

Interventions

DRUG

Topotecan (<=8cc)

In predominantly enhancing mass with a volume of 8 cc or less of topotecan administered

DRUG

Topotecan (>8cc)

In predominantly enhancing mass with a volume of \> 8 cc of topotecan administered. Initial rate is 0.834ml/hour with an increase to 1.668 ml/hour at the second infusion

DEVICE

Cleveland Multiport Catheter

an investigational device, will be used to deliver the topotecan

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

to monitor the infusion of topotecan into the tumor

DRUG

Lower Does Topotecan

Rate for non-enhancing tumors has an initial dose of 0.29ml/hour

Sponsors & Collaborators

  • Infuseon Therapeutics, Inc.

    collaborator INDUSTRY

  • Michael Vogelbaum, MD, PhD

    lead OTHER

Principal Investigators

  • Michael A. Vogelbaum, MD, PhD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2018-11-19
Completion
2018-11-19
FDA Drug
Yes
FDA Device
Yes

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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 NCT03193463 on ClinicalTrials.gov