Study of Intraparenchymal Therapy With Irinotecan Drug Eluting Beads as Adjunct to Recurrent Surgically Resectable High Grade Glioma (IDEB-glioma)
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|ClinicalTrials.gov Identifier: NCT02481960|
Recruitment Status : Unknown
Verified May 2015 by BTG International Inc..
Recruitment status was: Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : October 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Procedure: CM-BC2 Irinotecan drug-eluting bead||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Treatment arm
Intraparenchymal administration of CM-BC2 irinotecan drug-eluting bead in recurrent high grade glioma.
Procedure: CM-BC2 Irinotecan drug-eluting bead
Other Name: IDEB
- Safety measured by incidence of adverse events as assessed by CTCAE v4 [ Time Frame: 6 months ]safety as measured by adverse events including changes in physical exams, neurological function
- Progression-free survival [ Time Frame: Progression-free survival at 6 months ]progression as assessed by MRI and date of death
- Serum levels of irinotecan [ Time Frame: 6 months ]serum levels of drug (irinotecan)
- Serum levels of SN-38, irinotecan metabolite [ Time Frame: 6 months ]serum levels of drug metabolite (SN-38)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481960
|Centre Hopsitalier Universitaire d'Angers|
|Angers, France, 49933|
|Prof. Erol Sandalcioglu|
|Hannover, Germany, 30167|