A Phase II Trial of a Personalized, Dose-Intense Administration Schedule of
177Lu-DOTATATE
PRRT
high-risk
neuroblastoma
radiopharmaceutical
refractory
relapse
therapy
Journal
Frontiers in pediatrics
ISSN: 2296-2360
Titre abrégé: Front Pediatr
Pays: Switzerland
ID NLM: 101615492
Informations de publication
Date de publication:
2022
2022
Historique:
received:
15
12
2021
accepted:
31
01
2022
entrez:
1
4
2022
pubmed:
2
4
2022
medline:
2
4
2022
Statut:
epublish
Résumé
Half the children with high-risk neuroblastoma die with widespread metastases. Molecular radiotherapy is an attractive systemic treatment for this relatively radiosensitive tumor. The LuDO-N trial is a phase II, open label, multi-center, single arm, two stage design clinical trial. Children aged 18 months to 18 years are eligible. The trial is conducted by the Nordic Society for Pediatric Hematology and Oncology (NOPHO) and it has been endorsed by SIOPEN (https://www.siopen.net). The Karolinska University Hospital, is the sponsor of the LuDO-N trial, which is conducted in collaboration with Advanced Accelerator Applications, a Novartis company. All Scandinavian countries, Lithuania and the Netherlands participate in the trial and the UK has voiced an interest in joining in 2022. The pediatric use of the Investigational Medicinal Product (IMP) In this paper we present the protocol of the LuDO-N Trial. The rationale and design of the trial are discussed in relation to other ongoing, or planned trials with similar objectives. Further, we discuss the rapid development of targeted radiopharmaceutical therapy and the future perspectives for developing novel therapies for high-risk neuroblastoma and other pediatric solid tumors.
Sections du résumé
Background
UNASSIGNED
Half the children with high-risk neuroblastoma die with widespread metastases. Molecular radiotherapy is an attractive systemic treatment for this relatively radiosensitive tumor.
Methods
UNASSIGNED
The LuDO-N trial is a phase II, open label, multi-center, single arm, two stage design clinical trial. Children aged 18 months to 18 years are eligible. The trial is conducted by the Nordic Society for Pediatric Hematology and Oncology (NOPHO) and it has been endorsed by SIOPEN (https://www.siopen.net). The Karolinska University Hospital, is the sponsor of the LuDO-N trial, which is conducted in collaboration with Advanced Accelerator Applications, a Novartis company. All Scandinavian countries, Lithuania and the Netherlands participate in the trial and the UK has voiced an interest in joining in 2022.
Results
UNASSIGNED
The pediatric use of the Investigational Medicinal Product (IMP)
Discussion
UNASSIGNED
In this paper we present the protocol of the LuDO-N Trial. The rationale and design of the trial are discussed in relation to other ongoing, or planned trials with similar objectives. Further, we discuss the rapid development of targeted radiopharmaceutical therapy and the future perspectives for developing novel therapies for high-risk neuroblastoma and other pediatric solid tumors.
Identifiants
pubmed: 35359899
doi: 10.3389/fped.2022.836230
pmc: PMC8960300
doi:
Banques de données
ClinicalTrials.gov
['NCT04903899']
Types de publication
Journal Article
Langues
eng
Pagination
836230Informations de copyright
Copyright © 2022 Sundquist, Georgantzi, Jarvis, Brok, Koskenvuo, Rascon, van Noesel, Grybäck, Nilsson, Braat, Sundin, Wessman, Herold, Hjorth, Kogner, Granberg, Gaze and Stenman.
Déclaration de conflit d'intérêts
This study received funding from Applied Accelerator Applications, a Novartis company. The funder had the following involvement with the study: Advice on trial design, provision of all investigational and non-investigational products, free of charge for the LuDO-N trial and review of the final manuscript. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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