LuDO-N
Research type
Research Study
Full title
LuDO-N trial: A phase II trial of dose intense 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma
IRAS ID
1006922
Contact name
Jakob Stenman
Contact email
Sponsor organisation
Karolinska University Hospital
Eudract number
2020-004445-36
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Neuroblastoma is the most common paediatric extra-cranial solid tumour. Between a half and two thirds of patients will have high-risk disease. Despite highly intensive and varied treatments, these patients still experience a low long-term survival of about 50% and chances of survival after disease recurrence are poor. The study aims to improve the survival and quality of life of children and young people with high-risk neuroblastoma and gain knowledge to improve the treatment of other patients in the future. The countries taking part in the study are: Denmark, Finland, Iceland, Norway, Sweden, Lithuania, the Netherlands and UK. This trial is funded in the UK by Cancer Research UK and Novartis. The treatment plan includes 2 intravenous injections, 2 weeks apart, of a radioactive substance called 177Lutetium-DOTATATE (LuDO). LuDO targets somatostatin receptors, which are proteins present in the majority of neuroblastoma tumours in children. In a previous study with LuDO, the treatment was shown to be safe, and some signs of efficacy were seen, but the trial did not achieve the anticipated effect with the low-dose schedule used. The now proposed study (LuDO-N) will use a higher dose of LuDO, given over a shorter period of time, and aims to 1. confirm the dose, 2. assess response to the treatment LUDO in patients with relapsed or refractory high-risk neuroblastoma, 3.assess long term survival and 4. any treatment-related toxicity. This strategy requires a readiness for stem cell transplantation in all patients but is not expected to increase the risk of long-term side effects. The duration of the trial is 5 years from the end of treatment. The study will contribute to develop a new type of targeted treatment that, if shown to be effective, may be beneficial for patients in future international treatment protocols.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0015
Date of REC Opinion
27 Feb 2024
REC opinion
Further Information Favourable Opinion