A phase II single-arm study of irinotecan in combination with temozolomide (TEMIRI) in children with newly diagnosed high grade glioma: ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-05

AUTHORS

Darren Hargrave, Birgit Geoerger, Didier Frappaz, Torsten Pietsch, Lyle Gesner, Laura Cisar, Aurora Breazna, Andrew Dorman, Ofelia Cruz-Martinez, Jose Luis Fuster, Xavier Rialland, Céline Icher, Pierre Leblond, David Ashley, Giorgio Perilongo, Martin Elliott, Martin English, Niels Clausen, Jacques Grill

ABSTRACT

A multicenter, two stage phase II study, investigated irinotecan plus temozolomide in children with newly diagnosed high grade glioma. The primary endpoint was tumor response during a two-cycle treatment window, confirmed by external review committee. Patients received oral temozolomide 100 mg/(m(2) day) (days 1-5) and intravenous irinotecan 10 mg/(m(2) day) (days 1-5 and 8-12) for two 21-day cycles (three cycles for patients exhibiting objective tumor response). Standard treatment was then administered according to local investigator choice. In total 17 patients were enrolled and treated by local investigators. However, central pathology review found three patients did not have a diagnosis of high grade glioma and another four patients did not have evaluable disease according to independent central radiological review. The primary endpoint was based on the first ten evaluable patients as determined by the external review committee. Recruitment was stopped for futility after there were no complete or partial responses during the two-cycle treatment window in the first ten evaluable patients. Five patients had stable disease, and five progressed. Data for secondary endpoints including; time to tumor progression, time to treatment failure, and overall survival is reported. The safety profile of the treatment showed the combination was tolerable with two patients (11.8 %) having grade three nausea, and one (5.9 %) experiencing a grade four neutropenia, leading to permanent discontinuation from adjuvant treatment. Irinotecan plus temozolomide, although well tolerated did not improve outcome over historical controls in this setting. More... »

PAGES

127-134

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11060-013-1098-2

DOI

http://dx.doi.org/10.1007/s11060-013-1098-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1039243927

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23459995


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450 schema:name Centre Oscar-Lambret, Unité d’Oncologie Pédiatrique, Lille, France
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452 https://www.grid.ac/institutes/grid.498025.2 schema:alternateName Birmingham Women’s and Children’s NHS Foundation Trust
453 schema:name Paediatric Oncology, Birmingham Children’s Hospital NHS Foundation Trust, Birmingham, UK
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456 schema:name Paediatric Oncology Unit, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
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459 https://www.grid.ac/institutes/grid.5608.b schema:alternateName University of Padua
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462 https://www.grid.ac/institutes/grid.5841.8 schema:alternateName University of Barcelona
463 schema:name Servicios de Pediatría, Unidad Integrada Hospital Sant Joan de Déu-Clínic, Universidad de Barcelona, Barcelona, Spain
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