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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Centre Hopsitalier Universitaire d'Angers
Angers, France
Prof. Erol Sandalcioglu
Hanover, Germany
Safety measured by incidence of adverse events as assessed by CTCAE v4
safety as measured by adverse events including changes in physical exams, neurological function
Time frame: 6 months
Progression-free survival
progression as assessed by MRI and date of death
Time frame: Progression-free survival at 6 months
Serum levels of irinotecan
serum levels of drug (irinotecan)
Time frame: 6 months
Serum levels of SN-38, irinotecan metabolite
serum levels of drug metabolite (SN-38)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.