VCN-01 BRAIN
Research type
Research Study
Full title
A clinical study to evaluate the biological effects of preoperative intravenous administration of VCN-01 in patients prior to surgical resection of high-grade brain tumours
IRAS ID
283902
Contact name
Adel Samson
Contact email
Eudract number
2020-003405-59
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This clinical trial will evaluate the biological effects of intravenous administration of virus VCN-01 in patients prior to surgical resection of high-grade brain tumours.
Oncolytic virus-based immunotherapies are emerging as a promising anticancer strategy being tested in numerous clinical trials and which have already received FDA approval for the treatment of melanoma patients.
Currently, the median survival of high-grade glioma patients receiving the most optimal accessible treatment is 14.6 months (whilst those with a single brain metastasis will survive only up to 10 months), therefore novel more effective therapies are required.
VCN-01 is the altered form of the human adenovirus, which was genetically modified to improve its oncolytic properties (tumour selectivity and anti-tumour activity).
This study aims to assess whether the VCN-01 can access high-grade brain tumours following intravenous administration and to evaluate the safety of the proposed trial treatment. The study findings will potentially contribute to the development of new safe and effective treatment of brain cancer patients.
This is a phase 1b open-label, non-randomised, single-centre study. The total number of patients to be recruited is 12. Patients will receive a single dose of VCN-01. Patients recruited to the study will be over 16 years of age and with radiologically and/or histologically diagnosed recurrent high-grade primary or secondary brain tumours, planned for surgical resection. VCN-01 will be administered directly into a vein to the patients who are due to have their brain tumour surgically removed. The brain tumour will be examined for the presence of the virus after it has been surgically removed to see whether it has had any effect in killing the tumour cells. The patient’s safety and immune response to the virus will also be monitored and evaluated.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0061
Date of REC Opinion
5 May 2021
REC opinion
Further Information Favourable Opinion