dc.contributor.author | García Moure, Marc | |
dc.contributor.author | Gállego Pérez de Larraya, Jaime | |
dc.contributor.author | Patiño García, Ana | |
dc.contributor.author | González Huarriz, Marisol | |
dc.contributor.author | Jones, Chris | |
dc.contributor.author | MacKay, Alan | |
dc.contributor.author | Van der Lugt, Jasper | |
dc.contributor.author | Hulleman, Esther | |
dc.contributor.author | De Andrea, Carlos | |
dc.contributor.author | Astigarraga Aguirre, María Iciar | |
dc.contributor.author | García Ariza, Miguel Angel | |
dc.contributor.author | López Ibor, Blanca | |
dc.contributor.author | Villalba, María | |
dc.contributor.author | Lang, Frederick F. | |
dc.contributor.author | Fueyo, Juan | |
dc.contributor.author | Gómez Manzano, Candelaria | |
dc.contributor.author | Dobbs, Jessica | |
dc.contributor.author | Díez Valle, Ricardo | |
dc.contributor.author | Alonso, Marta M. | |
dc.contributor.author | Tejada, Sonia | |
dc.date.accessioned | 2021-08-11T10:09:15Z | |
dc.date.available | 2021-08-11T10:09:15Z | |
dc.date.issued | 2021-06-01 | |
dc.identifier.citation | Neuro-Oncology 23(1) : (2021) // Article ID i47 | es_ES |
dc.identifier.issn | 1522-8517 | |
dc.identifier.issn | 1523-5866 | |
dc.identifier.uri | http://hdl.handle.net/10810/52829 | |
dc.description.abstract | Background
A Phase 1, single center study is ongoing to evaluate the conditionally replicative oncolytic adenovirus, DNX-2401 (tasadenoturev), followed by radiotherapy (RT) in pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
Methods
Patients 1–18 years with newly diagnosed DIPG with no prior treatment, Lansky/Karnofsky performance score ≥ 70, and adequate organ function were enrolled. A tumor biopsy was performed followed by a single intratumoral injection of 1e10-5e10 virus particles (vp) DNX-2401. Conventional radiotherapy was initiated within 1 month of DNX-2401 administration.
Results
Enrolled subjects (n=12) had a median age of 9 (range 3–18) and performance scores of 90–100 (n=4; 33%) or 70–80 (n=8; 67%). As part of a dose escalation design, subjects were treated with 1e10 vp (n=4) or 5e10 vp DNX-2401 (n=8), which was then followed by standard RT in 11 of 12 subjects (92%). No dose-limiting toxicities were observed and the treatment regimen was well-tolerated. Adverse events (AEs) have been primarily mild to moderate and consistent with underlying disease. The most commonly reported AEs (≥ 5 subjects), regardless of study drug relationship, include headache, asthenia, vomiting, anemia, leukocytosis, and fever. Two SAEs have been reported including grade 3 lymphopenia and grade 3 abdominal pain. Tumor reductions have been observed and efficacy evaluations are ongoing. As of 09Dec2020, 12-month survival (OS-12) was 71% and 4 of 12 patients had survived > 20 months. Four subjects continue to be followed for survival. Correlative analysis of tumor biopsy and peripheral samples is ongoing.
Conclusions
DNX-2401 followed by RT can be safely administered to pediatric subjects with newly diagnosed DIPG; clinical activity and preliminary survival are encouraging. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Oxford University Press | es_ES |
dc.rights | info:eu-repo/semantics/openAccess | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | * |
dc.subject | anemia | es_ES |
dc.subject | radiation therapy | es_ES |
dc.subject | abdominal pain | es_ES |
dc.subject | adenoviruses | es_ES |
dc.subject | biopsy | es_ES |
dc.subject | fever | es_ES |
dc.subject | headache | es_ES |
dc.subject | asthenia | es_ES |
dc.subject | karnofsky performance status | es_ES |
dc.subject | leukocytosis | es_ES |
dc.subject | lymphopenia | es_ES |
dc.subject | pediatrics | es_ES |
dc.subject | virion | es_ES |
dc.subject | vomiting | es_ES |
dc.subject | neoplasms | es_ES |
dc.subject | toxic effect | es_ES |
dc.subject | adverse event | es_ES |
dc.subject | diffuse intrinsic pontine glioma | es_ES |
dc.title | Results of A Phase 1 study of the oncolytic adenovirus DNX-2401 with radiotherapy for newly diagnosed diffuse intrinsic pontine glioma (DIPG) | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.rights.holder | This is an Open Access article distributed under the terms of the Creative Commons Attribution Non Commercial License (CC BY-NC 4.0) | es_ES |
dc.rights.holder | Atribución-NoComercial 3.0 España | * |
dc.relation.publisherversion | https://academic-oup-com.ehu.idm.oclc.org/neuro-oncology/article/23/Supplement_1/i47/6288280 | es_ES |
dc.identifier.doi | 10.1093/neuonc/noab090.190 | |
dc.departamentoes | Pediatría | es_ES |
dc.departamentoeu | Pediatria | es_ES |