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

EARLY_PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 3, 2017

Primary Completion Date

November 19, 2018

Study Completion Date

November 19, 2018

Conditions
Glioma
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
All Listed Sponsors
collaborator

Infuseon Therapeutics, Inc.

INDUSTRY

lead

Michael Vogelbaum, MD, PhD

OTHER