Trials / Terminated
TerminatedNCT02481960
Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CM-BC2 Irinotecan drug-eluting bead |
Timeline
- Start date
- 2012-02-21
- Primary completion
- 2015-12-18
- Completion
- 2015-12-18
- First posted
- 2015-06-25
- Last updated
- 2021-04-21
Locations
2 sites across 2 countries: France, Germany
Source: ClinicalTrials.gov record NCT02481960. Inclusion in this directory is not an endorsement.