Evidence map›Paper›PMID 33438318›Full record

ArticlePediatric blood & cancer2021

A phase 1 study of entinostat in children and adolescents with recurrent or refractory solid tumors, including CNS tumors: Trial ADVL1513, Pediatric Early Phase-Clinical Trial Network (PEP-CTN).

Andrew Bukowinski, Bill Chang, Joel M Reid, Xiaowei Liu, Charles G Minard, Jane B Trepel, Min-Jung Lee, Elizabeth Fox, Brenda J Weigel

Open access · greenAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Pediatric blood & cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
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  11. Mechanisms of HDACs in cancer development.Frontiers in immunology · 2025
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  14. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
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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

9 authors at 8 institutions in 1 country.

Andrew BukowinskiDivision of Pediatric Hematology Oncology, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania.ORCID 0000-0002-3793-9340
Bill ChangDivision of Pediatric Hematology Oncology, Oregon Health and Science University, Portland, Oregon.
Joel M ReidMayo Clinic, Rochester, Minnesota.
Xiaowei LiuChildren's Oncology Group, Operation Center, Monrovia, California.
Charles G MinardInstitute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas.
Jane B TrepelDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Min-Jung LeeDevelopmental Therapeutics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Elizabeth FoxDepartment of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.
Brenda J WeigelDepartment of Pediatrics, University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota.
National Institutes of Health · USBaylor College of Medicine · USChildren's Hospital of Pittsburgh · USChildren's Oncology Group · USMayo Clinic · USOregon Health & Science University · USSt. Jude Children's Research Hospital · USUniversity of Minnesota · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
PEP-CTN EHR to RAVE supplementUM1CA228823 · NCI · PUBLIC HEALTH INSTITUTE · PI Elizabeth Fox · 2018 to 2026
$39.6M
Signal Transduction Events and the Regulation of Cell GrowthZICSC006743 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI TREPEL, JANE B · 2009 to 2023
$13.8M
SIGNAL TRANSDUCTION EVENTS AND THE REGULATION OF CELL GROWTHZ01SC006743 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI TREPEL, JANE B · 1996 to 2008
$1.9M
Intramural NIH HHS Z01 SC006743Intramural NIH HHS ZIC SC006743NCI NIH HHS P30 CA015083NCI NIH HHS UM1 CA228823NIH HHS UM1 CA228823NIH HHS ZIC SC 006743
6 · The paper itself

Abstract

backgroundEntinostat is an oral small molecule inhibitor of class I histone deacetylases (HDAC), which has not previously been evaluated in pediatrics. We conducted a phase I trial to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D), toxicity profile, pharmacokinetics (PK), and pharmacodynamics (PD) of entinostat in children with relapsed or refractory solid tumors including central nervous system (CNS) malignancies.

methodsA rolling six dose escalation design evaluated two dose levels. Entinostat oral tablet formulation was administered once per week, four doses per 28-day cycle. PK and PD studies were performed.

resultsTwenty-one eligible patients' median (range) age was 14 years (6-20). Six subjects were treated at 3 mg/m

conclusionsEntinostat was well tolerated with no DLT observed. All patients experienced progression within the first two cycles, except one patient with ependymoma with stable disease. Based on PK and PD, the R2PD in pediatric patients with solid tumors is 4 mg/m

Indexed as

AdolescentAdultAntineoplastic AgentsBenzamidesCentral Nervous System NeoplasmsChildFemaleHumansMaleMaximum Tolerated DoseNeoplasm Recurrence, LocalNeoplasmsPyridinesSarcomaYoung AdultAntineoplastic AgentsBenzamidesentinostatPyridinesEwing sarcomaglioma low gradeneuro-oncologyoncology generalosteosarcomapediatric hematology oncologypediatric oncologyphase 1 clinical trial agentsphase 1 studyrhabdomyosarcoma

Identifiers

PMID33438318
PMCPMC9176707
OpenAlexW3119290178

What OpenQuestion holds

Textmetadata
LicenceTDM
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.