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Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma — IDEB-glioma  

Glioma Clinical Trial

Official title:
A Phase I/II Multi Centre Single Arm, Open Label Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as a Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable High Grade Glioma

Clinical Trial Summary

A study to demonstrate safety, and feasibility for intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent high grade glioma (HGG).

Clinical Trial Description

CM-BC2, irinotecan hydrochloride drug-eluting bead, is an investigational product being developed for direct injection in the tumor resection margin, in patients with recurrent high grade glioma (HGG), in order to prevent or delay tumor progression or recurrence. Patients will be enrolled and receive CM-BC2 following surgical resection of the recurrent high grade glioma and will attend specified study visits until 6 months post surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02481960
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date February 21, 2012
Completion date December 18, 2015
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