irinotecan-ChemoSeed in Surgically Resectable Glioblastoma
Research type
Research Study
Full title
Open-label Phase 2 Safety and Efficacy Trial of irinotecan-ChemoSeed Administered Directly into the Resection Margin in Patients with Surgically Resectable Glioblastoma
IRAS ID
1012556
Contact name
Andrew Webb
Contact email
Sponsor organisation
CRISM Therapeutics Limited
Research summary
The main purpose of this study is to investigate how safe and effective irinotecan-ChemoSeed is in treating and slowing down the progression of glioblastoma ( a type of brain cancer). The patients enrolled in the study are planned to have surgery to remove their brain tumour.
irinotecan-ChemoSeed is an experimental drug which means that it is not currently approved for use as treatment in the UK. irinotecan-ChemoSeed is a new type (“formulation”) of a common anti-cancer medicine called irinotecan. Irinotecan-ChemoSeed is made by mixing irinotecan with a polymer called poly lacticco-glycolic acid (PLGA). This is then inserted into the gap left after the tumour is removed from the brain during surgery.
There are two parts to this study:
Part 1 of this study: For patients with recurrent glioblastoma (glioblastoma that has come back after treatment), the researchers conducting this study want to find out what effects, good and bad, irinotecan-ChemoSeed has on the patient and their glioblastoma.
Part 2 of this study: For patients with newly diagnosed glioblastoma, the researchers conducting this study want to compare the effects, good and bad, of irinotecan-ChemoSeed with commonly used “standard of care” treatment on the patient and their glioblastoma to see which is better.
In total, 147 participants are expected to participate in this study, which will be conducted at different sites in the UK. Patients will actively be in the study for at least 6 months if participating in Part 1 or 12 months if participating in Part 2. Patients will be asked to come to the clinic approximately 7 times during the first 2 months of the study. Patients in Part 2 may be offered additional standard of care treatment and will also need to go to the hospital up to 30 times for that treatment. The patient will then need to visit the study site every 8 weeks for long-term follow-up.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0238
Date of REC Opinion
26 Aug 2025
REC opinion
Further Information Favourable Opinion