Evidence map›Paper›PMID 34347089›Full record

Trial reportNeuro-oncology2022

Phase I/II trial of vorinostat and radiation and maintenance vorinostat in children with diffuse intrinsic pontine glioma: A Children's Oncology Group report.

Jack M Su, Lindsay B Kilburn, David B Mansur, Mark Krailo, Allen Buxton, Adesina Adekunle, Amar Gajjar, Peter C Adamson, Brenda Weigel, Elizabeth Fox and 2 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Neuro-oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Pooled it
  2. Unraveling the role of specificity protein 1 in gliomas: pathophysiology and clinical implications.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Central nervous system distributional kinetics of selected histone deacetylase inhibitors.The Journal of pharmacology and experimental therapeutics · 2025
    Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. Article
  19. Advances in Treatment of Diffuse Midline Gliomas.Current neurology and neuroscience reports · 2023
    Review
  20. Posterior fossa tumors in children: current insights.European journal of pediatrics · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 1 country.

Jack M SuTexas Children's Cancer Center, Baylor College of Medicine, Houston, Texas, USA.
Lindsay B KilburnCenter for Cancer & Blood Disorders, Children's National Medical Center, Washington DC, USA.
David B MansurDepartment of Radiation Oncology, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.
Mark KrailoDepartment of Statistics, Children's Oncology Group, Monrovia, California, USA.
Allen BuxtonDepartment of Statistics, Children's Oncology Group, Monrovia, California, USA.
Adesina AdekunleDepartment of Pathology, Texas Children's Hospital, Houston, Texas, USA.
Amar GajjarDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Peter C AdamsonGlobal Head, Oncology Development, Sanofi, Cambridge, Massachussetts, USA.
Brenda WeigelDepartment of Pediatrics, Hem/Onc/BMT, University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, USA.
Elizabeth FoxDepartment of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Susan M BlaneyTexas Children's Cancer Center, Baylor College of Medicine, Houston, Texas, USA.
Maryam FouladiNeuro-Oncology Program, Nationwide Children's Hospital, Columbus, Ohio, USA.ORCID 0000-0002-5693-035X
Baylor College of Medicine · USChildren's Oncology Group · USSt. Jude Children's Research Hospital · USChildren's National · USNationwide Children's Hospital · USRainbow Babies & Children's Hospital · USSanofi (United States) · USTexas Children's Hospital · USUniversity of Minnesota · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS U24 CA180803
6 · The paper itself

Abstract

backgroundA phase I/II trial of vorinostat (suberoylanilide hydroxamic acid), an oral histone deacetylase inhibitor, was conducted in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) through the Children's Oncology Group (COG) to: 1) determine the recommended phase II dose (RP2D) of vorinostat given concurrently with radiation therapy; 2) document the toxicities of continuing vorinostat as maintenance therapy after radiation; and 3) to determine the efficacy of this regimen by comparing the risk of progression or death with a historical model from past COG trials.

methodsVorinostat was given once daily, Monday through Friday, during radiation therapy (54 Gy in 30 fractions), and then continued at 230 mg/m2 daily for a maximum of twelve 28-day cycles.

resultsTwelve patients enrolled in the phase I study; the RP2D of vorinostat given concurrently with radiation was 230 mg/m2/day, Monday through Friday weekly. The six patients enrolled at the RP2D and an additional 64 patients enrolled in the phase II study contributed to the efficacy assessment. Although vorinostat was well-tolerated, did not interrupt radiation therapy, and was permanently discontinued in only 8.6% of patients due to toxicities, risk for EFS-event was not significantly reduced compared with the target risk derived from historical COG data (P = 0.32; 1-sided). The 1-year EFS was 5.85% (95% CI 1.89-13.1%) and 1-year OS was 39.2% (27.8-50.5%).

conclusionsVorinostat given concurrently with radiation followed by vorinostat monotherapy was well tolerated in children with newly diagnosed DIPG but failed to improve outcome.

Indexed as

AstrocytomaBrain Stem NeoplasmsDiffuse Intrinsic Pontine GliomaChildHistone Deacetylase InhibitorsHumansHydroxamic AcidsVorinostatHistone Deacetylase InhibitorsHydroxamic AcidsVorinostatchildrendiffuse intrinsic pontine gliomaphase I/II clinical trialssuberoylanilide hydroxamic acidVorinostat

Identifiers

PMID34347089
PMCPMC8972206
OpenAlexW3193070114

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.