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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CM-BC2 is a drug-eluting bead, a drug-device combination
Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Safety measured by incidence of adverse events as assessed by CTCAE v4.0
safety of intraparenchymal injection of CM-BC2
Time frame: 6 months
Progression-free survival
Progression-free Survival (PFS) at 6 months
Time frame: 6 months
Systemic serum levels of irinotecan
Serum levels of drug (irinotecan)
Time frame: 6 months
Systemic serum levels of SN-38, irinotecan metabolite
Serum levels of drug metabolite (SN-38)
Time frame: 6 months
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