NCT02433392

Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Resectable Glioblastoma Multiforme.

A Phase 1 Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as an Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable Glioblastoma Multiforme.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the safety and feasibility of injecting irinotecan hydrochloride drug-eluting beads directly into the cavity remaining after a tumor is surgically removed in patients with a type of brain tumor (glioblastoma multiforme - also known as glioma) that has returned after prior therapy.

Detailed description

A challenge in the treatment of glioma is the delivery of treatment to the brain after systemic administration due to the blood brain barrier. To improve drug delivery to the brain to achieve very high local concentrations of the anti-neoplastic agent with low system toxicity, a local regional approach is proposed. CM-BC2, an irinotecan hydrochloride drug-eluting bead, is an investigational medicinal product intended for direction injection into the tumor resection margin. The objective of this trial is demonstration of safety and feasibility of this intraparenchymal injection of irinotecan hydrochloride drug-eluting beads in the treatment of recurrent Glioblastoma multiforme.

Conditions

• Glioma

Interventions

Type	Name	Description
PROCEDURE	CM-BC2	CM-BC2 is a drug-eluting bead, a drug-device combination

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-05-05
• Last updated: 2021-04-21

Locations

1 site across 1 country: United Kingdom