CamBMT1
Research type
Research Study
Full title
Cambridge Brain Mets Trial 1: A proof-of-principle phase 1b / randomised phase 2 study of afatinib penetration into cerebral metastases for patients undergoing neurosurgical resection, both with and without prior low-dose, targeted radiotherapy
IRAS ID
146009
Contact name
Richard Baird
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2013-002398-23
Research summary
The CamBMT1 trial has been designed to try and improve the treatment of cancers that have spread to the brain (sometimes known as brain metastases, or secondary brain tumours).
In the past it has been found that many anti-cancer drugs are unable to cross over from the bloodstream into brain tumours because of a system called the blood brain barrier, which can stop drugs getting through.
In addition to the standard operation for their brain cancer, participants in the CamBMT1 trial will receive 11 days of an anti-cancer drug called afatinib whilst they are waiting for their operation. We will directly test in the lab how much drug has got into brain tumours from different patients, after the tumours have been removed at surgery.
Before their operation, some patients will also receive a single low-dose of radiotherapy focused on the brain cancer.
The study has been designed to test how much afatinib actually gets past the blood brain barrier into the brain cancer, and also whether the single low-dose of radiotherapy might open up the barrier and allow increased drug delivery into the cancer. If this proves true, it might provide an effective, safe and important strategy to improve treatment for patients with cancer that has spread to the brain.
We plan to include 70-96 patients from at least 3 teaching hospitals across the UK. Recruitment is planned to last approximately 3.5 years.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1172
Date of REC Opinion
22 Sep 2014
REC opinion
Favourable Opinion