Evidence map›Paper›PMID 33034839›Full record

Trial reportJournal of neuro-oncology2020

A phase I/II study of ribociclib following radiation therapy in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).

Mariko DeWire, Christine Fuller, Trent R Hummel, Lionel M L Chow, Ralph Salloum, Peter de Blank, Luke Pater, Sarah Lawson, Xiaoting Zhu, Phil Dexheimer and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02607124 (A Phase I/II Study of Ribociclib, a CDK4/6 Inhibitor, Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT02607124 phase1 / phase2terminatednot on this map

A Phase I/II Study of Ribociclib, a CDK4/6 Inhibitor, Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2016 to 2018Enrolled11ConditionsHigh Grade Glioma, Diffuse Intrinsic Pontine Glioma, Bithalamic High Grade GliomaArmsRibociclib
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Article
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  7. Review
  8. Small-Molecule Drugs in Pediatric Neuro-Oncology.Current oncology (Toronto, Ont.) · 2025
    Review
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  11. Review
  12. Article
  13. Article
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  15. Article
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  18. Advances in Treatment of Diffuse Midline Gliomas.Current neurology and neuroscience reports · 2023
    Review
  19. Article
  20. 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

20 authors at 2 institutions in 1 country.

Mariko DeWireDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA. mariko.dewire@cchmc.org.ORCID http://orcid.org/0000-0002-8084-2720
Christine FullerDivision of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Trent R HummelDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Lionel M L ChowDepartment of Hematology/Oncology, Dayton Children's Hospital, Dayton, OH, USA.
Ralph SalloumDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Peter de BlankDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Luke PaterDepartment of Radiation Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Sarah LawsonDepartment of Endocrinology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Xiaoting ZhuDepartment of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Phil DexheimerDepartment of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Adam C CarleDepartment of Pediatrics, Department of Psychology, College of Medicine University of Cincinnati, College of Arts and Sciences University of Cincinnati, Anderson Center Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Shiva Senthil KumarDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Rachid DrissiDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Charles B StevensonDivision of Neurosurgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Adam LaneDepartment of Biostatistics, Cincinnati, OH, USA.
John BrenemanDepartment of Radiation Oncology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
David WitteDivision of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Blaise V JonesDepartment of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
James L LeachDepartment of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Maryam FouladiDivision of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Cincinnati Children's Hospital Medical Center · USDayton Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCyclin-dependent kinase-retinoblastoma (CDK-RB) pathway is dysregulated in some diffuse intrinsic pontine gliomas (DIPG). We evaluated safety, feasibility, and early efficacy of the CDK4/6-inhibitor ribociclib, administered following radiotherapy in newly-diagnosed DIPG patients.

methodsFollowing radiotherapy, eligible patients received ribociclib in 28-day cycles (350 mg/m

resultsThe study included 10 evaluable patients, 9 DIPG and 1 diffuse midline glioma (DMG)-all 3.7 to 19.8 years of age. The median number of courses was 8 (range 3-14). Three patients required dose reduction for grade-4 neutropenia, and 1 discontinued therapy for hematological toxicity following course 4. The most common grade-3/4 toxicity was myelosuppression. After 2 courses, MRI evaluations in 4 patients revealed increased necrotic volume, associated with new neurological symptoms in 3 patients. The 1-year and median OS for DIPG was 89% and 16.1 months (range 10-30), respectively; the DMG patient died at 6 months post-diagnosis. Five patients donated brain tissue and tumor; 3 were RB+ .

conclusionsRibociclib administered following radiotherapy is feasible in DIPG and DMG. Increased tumor necrosis may represent a treatment effect. These data warrant further prospective volumetric analyses of tumors with necrosis. Feasibility and stabilization findings support further investigation of ribociclib in combination therapies.

trial registrationNCT02607124.

Indexed as

AdolescentAdultAminopyridinesBrain Stem NeoplasmsChemoradiotherapyChildChild, PreschoolDiffuse Intrinsic Pontine GliomaFemaleFollow-Up StudiesHumansMaleMaximum Tolerated DosePrognosisPurinesTissue DistributionAminopyridinesPurinesribociclibPediatric diffuse intrinsic pontine glioma (DIPG)Pediatric diffuse midline glioma (DMG)Ribociclib

Identifiers

PMID33034839
OpenAlexW3092538239

What OpenQuestion holds

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Registered trials

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.