Interleukin-1 in Vestibular Schwannoma (IL-VS)
Research type
Research Study
Full title
Interleukin-1 in Vestibular Schwannoma (IL-VS): A biomarker development study
IRAS ID
347607
Contact name
Andrew King
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
In vestibular schwannoma (VS), inflammation is associated with tumour growth and studies have shown that one chemical mediator of inflammation called interleukin-1 (IL-1) is increased in patients with growing VS. Targeting IL-1 through drugs such as Anakinra (Kineret ©) could reduce inflammation and growth in these tumours. The first step and this study aim though is to understand the best tests or biomarkers that can evaluate whether targeting Il-1 is having an effect within VS.
For this study ten patients due to undergo surgery for a growing sporadic or NF2-related Schwannomatosis VS at Salford Royal Hospital will be recruited. Participants will first undergo a research MRI scan for evaluation of tumour imaging biomarkers. Blood samples will also be collected so that levels of circulating pro-inflammatory chemicals (cytokines) can be evaluated. Following these tests, participants will receive a once-daily subcutaneous dose of an established safe IL-1 targeting drug called Anakinra (Kineret ©). This drug will be given for 14 days at home by a trained member of the research team, and at the end participants will then undergo the same MRI scan and blood tests described above so that changes can be measured. During planned surgery, excess tissue from the tumour (VS) will be taken and specialised tests used to look for changes in the expression of inflammation related genes and changes in the number of inflammatory cells. Data from Anakinra-dosed tumours will be compared with a control cohort of patients with growing sporadic VS who have undergone surgical resection. This cohort of patients, who are
being prospectively recruited under a separate NHS ethics will not undergo Anakinra administration but will have undergone the same MRI imaging and blood sampling protocol detailed above, with imaging and blood sample collection at day 0 and day 14 and blood sample collection just prior to surgery.REC name
South East Scotland REC 01
REC reference
25/SS/0001
Date of REC Opinion
10 Feb 2025
REC opinion
Further Information Favourable Opinion