Pain in anti-GD2 therapy
Research type
Research Study
Full title
A study to investigate the mechanism of pain in patients receiving Dinutuximab beta (anti-GD2) for the treatment of neuroblastoma.
IRAS ID
344279
Contact name
Alexander J Davies
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
2 years, 9 months, 26 days
Research summary
This study is a multi-centre observational, prospective registry of patients with high-risk neuroblastoma treated with Dinutuximab beta. Pain is an almost universal toxicity associated with anti-GD2 immunotherapy, and can be severe despite opioid analgesia.
The aim of the study is to better understand the mechanism of pain is patients receving this immunotherapy, with the ultimate aim of designing better, less toxic anti-GD2 antibodies. The study is non-interventional. All treatment decisions are made according to normal clinical practice and are not mandated by the protocol.
Data collection, assessment of pain experienced by participants and blood sampling in addition to those taken during routine clinical care will occur at baseline and during treatment. Data will be collected on Dinutuximab beta dose administered, dose interruptions and discontinuations, prophylactic and treatment doses of concomitant supportive care medications (e.g. analgesia), assessments of pain, occurrence of neurotoxicity or other toxicities, as well as serial blood sampling to characterise the immune reaction as well as seek evidence of biomarkers of neuronal damage.
REC name
London - Fulham Research Ethics Committee
REC reference
24/PR/1510
Date of REC Opinion
22 Jan 2025
REC opinion
Further Information Favourable Opinion