NCT03193463

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

Pilot Trial of Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive World Health Organization (WHO) Grade III or IV (High Grade) Glioma Undergoing Stereotactic Biopsy (IND 117,240)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Michael Vogelbaum, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives * To investigate by MR imaging the spatial and temporal distribution of topotecan in enhancing or nonenhancing bulk tumor 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 with recurrent/progressive HGG Secondary Objectives * To investigate the extent to which backflow may be observed on MRI during CEDmediated 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.

Conditions

• Glioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-03
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2017-06-20
• Last updated: 2019-03-01

Regulatory

• FDA-regulated drug study
• FDA-regulated device study