Evidence map›Paper›PMID 23836190›Full record

Trial reportJournal of neuro-oncology2013

A molecular biology and phase II trial of lapatinib in children with refractory CNS malignancies: a pediatric brain tumor consortium study.

Maryam Fouladi, Clinton F Stewart, Susan M Blaney, Arzu Onar-Thomas, Paula Schaiquevich, Roger J Packer, Stewart Goldman, J Russell Geyer, Amar Gajjar, Larry E Kun and 2 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of neuro-oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Ependymoma: Advances in Systems Treatment Strategies.Current neurology and neuroscience reports · 2025
    Review
  5. Review
  6. Article
  7. Sex Differences in Ependymoma Methylation by Methylation-Defined Subgroup.Journal of cellular and molecular medicine · 2024
    Article
  8. Article
  9. Article
  10. [Targeted Drug Therapy for Intracranial Tumors].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2022
    Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Maryam FouladiSt. Jude Children's Research Hospital, Memphis, TN, USA. maryam.fouladi@cchmc.org
Clinton F Stewart
Susan M Blaney
Arzu Onar-Thomas
Paula Schaiquevich
Roger J Packer
Stewart Goldman
J Russell Geyer
Amar Gajjar
Larry E Kun
James M Boyett
Richard J Gilbertson
St. Jude Children's Research Hospital · USBaylor College of Medicine · USChildren's National · USLurie Children's Hospital · USSeattle Children's Hospital · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
Pediatric Brain Tumor Consortium (PBTC)UM1CA081457 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI Ira J Dunkel, Arzu Onar-Thomas · 2014 to 2026
$41.4M
The Pediatric Brain Tumor Consortium (PBTC)U01CA081457 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI BOYETT, JAMES MILFORD · 1999 to 2013
$29.2M
Lapatinib in childhood CNS malignanciesR21CA114937 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI FOULADI, MARYAM · 2005 to 2006
$586k
NCI NIH HHS P30 CA021765NCI NIH HHS R21 CA114937NCI NIH HHS U01 CA081457NCI NIH HHS U01 CA81457NCI NIH HHS UM1 CA081457
6 · The paper itself

Abstract

High expression of ERBB2 has been reported in medulloblastoma and ependymoma; EGFR is amplified and over-expressed in brainstem glioma suggesting these proteins as potential therapeutic targets. We conducted a molecular biology (MB) and phase II study to estimate inhibition of tumor ERBB signaling and sustained responses by lapatinib in children with recurrent CNS malignancies. In the MB study, patients with recurrent medulloblastoma, ependymoma, and high-grade glioma (HGG) undergoing resection were stratified and randomized to pre-resection treatment with lapatinib 900 mg/m² dose bid for 7-14 days or no treatment. Western blot analysis of ERBB expression and pathway activity in fresh tumor obtained at surgery estimated ERBB receptor signaling inhibition in vivo. Drug concentration was simultaneously assessed in tumor and plasma. In the phase II study, patients, stratified by histology, received lapatinib continuously, to assess sustained response. Eight patients, on the MB trial (four medulloblastomas, four ependymomas), received a median of two courses (range 1-6+). No intratumoral target inhibition by lapatinib was noted in any patient. Tumor-to-plasma ratios of lapatinib were 10-20 %. In the 34 patients (14 MB, 10 HGG, 10 ependymoma) in the phase II study, lapatinib was well-tolerated at 900 mg/m² dose bid. The median number of courses in the phase II trial was two (range 1-12). Seven patients (three medulloblastoma, four ependymoma) remained on therapy for at least four courses range (4-26). Lapatinib was well-tolerated in children with recurrent or CNS malignancies, but did not inhibit target in tumor and had little single agent activity.

Indexed as

AdolescentAntineoplastic AgentsBlotting, WesternCentral Nervous System NeoplasmsChildChild, PreschoolEpendymomaErbB ReceptorsFemaleGliomaHumansInfantLapatinibMaleMedulloblastomaNeoplasm GradingAntineoplastic AgentsErbB ReceptorsLapatinibQuinazolines

Identifiers

PMID23836190
PMCPMC4246636
OpenAlexW1998310148

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.