{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T18:38:49Z","timestamp":1785523129597,"version":"3.56.0"},"reference-count":46,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T00:00:00Z","timestamp":1731974400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["U10 CA180886"],"award-info":[{"award-number":["U10 CA180886"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["U10 CA180899"],"award-info":[{"award-number":["U10 CA180899"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007052","name":"Memorial Sloan Kettering Cancer Center","doi-asserted-by":"publisher","award":["P30 CA008748"],"award-info":[{"award-number":["P30 CA008748"]}],"id":[{"id":"10.13039\/100007052","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The outcome for pediatric patients with high-grade glioma (HGG) remains poor. Veliparib, a potent oral poly(adenosine diphosphate-ribose) polymerase (PARP) 1\/2 inhibitor, enhances the activity of radiotherapy and DNA-damaging chemotherapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a single-arm, non-randomized phase 2 clinical trial to determine whether treatment with veliparib and radiotherapy, followed by veliparib and temozolomide, improves progression-free survival in pediatric patients with newly diagnosed HGG without H3 K27M or BRAF mutations, compared to patient-level data from historical cohorts with closely matching clinical and molecular features. Following surgical resection, newly diagnosed children with non-metastatic HGG were screened by rapid central pathology review and molecular testing. Eligible patients were enrolled on Stratum 1 (IDH wild-type) or Stratum 2 (IDH mutant).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Both strata were closed to accrual for futility after planned interim analyses. Among the 23 eligible patients who enrolled on Stratum 1 and received protocol therapy, the 1-year event-free survival (EFS) was 23% (standard error, SE\u2005=\u20059%) and the 1-year overall survival (OS) was 64% (SE\u2005=\u200510%). Among the 14 eligible patients who enrolled on Stratum 2 and received protocol therapy, the 1-year EFS was 57% (SE\u2005=\u200513%) and 1-year OS was 93% (SE\u2005=\u20050.7%).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Rapid central pathology review and molecular testing for eligibility were feasible. The protocol therapy including radiation, veliparib, and temozolomide was well tolerated but failed to improve outcomes compared to clinically and molecularly matched historical control cohorts treated with higher doses of alkylator chemotherapy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>ClinicalTrials.gov Identifier<\/jats:title>\n                  <jats:p>NCT03581292 (first posted: July 10, 2018).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/neuonc\/noae247","type":"journal-article","created":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T12:43:56Z","timestamp":1732020236000},"page":"1092-1101","source":"Crossref","is-referenced-by-count":11,"title":["Phase 2 trial of veliparib, local irradiation, and temozolomide in patients with newly diagnosed high-grade glioma: a Children\u2019s Oncology Group study"],"prefix":"10.1093","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7151-6528","authenticated-orcid":false,"given":"Matthias A","family":"Karajannis","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Memorial Sloan Kettering Cancer Center , New York, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1005-2413","authenticated-orcid":false,"given":"Arzu","family":"Onar-Thomas","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, St. Jude Children\u2019s Research Hospital , Memphis, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tong","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, St. Jude Children\u2019s Research Hospital , Memphis, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3703-8742","authenticated-orcid":false,"given":"Patricia A","family":"Baxter","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Texas Children\u2019s Hospital\/Baylor College of Medicine , Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel R","family":"Bou\u00e9","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Nationwide Children\u2019s Hospital , Columbus, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie L","family":"Cole","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology, University of Washington School of Medicine , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7919-7675","authenticated-orcid":false,"given":"Christine","family":"Fuller","sequence":"additional","affiliation":[{"name":"Department of Pathology, Upstate Medical University , Syracuse, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4673-9997","authenticated-orcid":false,"given":"Sofia","family":"Haque","sequence":"additional","affiliation":[{"name":"Department of Radiology, Memorial Sloan Kettering Cancer Center , New York, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2485-3692","authenticated-orcid":false,"given":"Nada","family":"Jabado","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, McGill University , Montreal, Quebec ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"John T","family":"Lucas","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, St. Jude Children\u2019s Research Hospital , Memphis, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon M","family":"MacDonald","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Massachusetts General Hospital , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Celeste","family":"Matsushima","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Wisconsin School of Medicine and Public Health , Madison, Wisconsin ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namrata","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Stanford Medicine Children\u2019s Health , Palo Alto, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher R","family":"Pierson","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Nationwide Children\u2019s Hospital , Columbus, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5627-4551","authenticated-orcid":false,"given":"Mark M","family":"Souweidane","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, Weill Cornell Medicine , New York, New York ,","place":["USA"]},{"name":"Department of Neurosurgery, Memorial Sloan-Kettering Cancer Center , New York, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana L","family":"Thomas","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Nationwide Children\u2019s Hospital , Columbus, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael F","family":"Walsh","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Memorial Sloan Kettering Cancer Center , New York, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7079-8105","authenticated-orcid":false,"given":"Wafik","family":"Zaky","sequence":"additional","affiliation":[{"name":"The University of Texas MD Anderson Cancer Center , Houston, Texas ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0225-6184","authenticated-orcid":false,"given":"Sarah E S","family":"Leary","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Washington School of Medicine , Seattle, Washington ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5019-0699","authenticated-orcid":false,"given":"Amar","family":"Gajjar","sequence":"additional","affiliation":[{"name":"Department of Pediatric Medicine, St Jude Children\u2019s Research Hospital , Memphis, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5693-035X","authenticated-orcid":false,"given":"Maryam","family":"Fouladi","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Nationwide Children\u2019s Hospital , Columbus, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth J","family":"Cohen","sequence":"additional","affiliation":[{"name":"The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins , Baltimore, MD ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,11,19]]},"reference":[{"issue":"2","key":"2025052712360782400_CIT0001","first-page":"153","article-title":"Pediatric high-grade glioma: Biologically and clinically in need of new thinking","volume":"19","author":"Jones","year":"2017","journal-title":"Neuro Oncol"},{"issue":"3","key":"2025052712360782400_CIT0002","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1093\/neuonc\/noq191","article-title":"Temozolomide in the treatment of high-grade gliomas in children: A report from the Children\u2019s Oncology Group","volume":"13","author":"Cohen","year":"2011","journal-title":"Neuro Oncol"},{"issue":"10","key":"2025052712360782400_CIT0003","doi-asserted-by":"crossref","first-page":"1442","DOI":"10.1093\/neuonc\/now038","article-title":"Phase 2 study of concurrent radiotherapy and temozolomide followed by temozolomide and lomustine in the treatment of 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