Evidence map›Paper›PMID 19065567›Full record

ArticlePediatric blood & cancer2009

Phase I study of SU5416, a small molecule inhibitor of the vascular endothelial growth factor receptor (VEGFR) in refractory pediatric central nervous system tumors.

Mark W Kieran, Jeffrey G Supko, Dana Wallace, Robert Fruscio, Tina Young Poussaint, Peter Phillips, Ian Pollack, Roger Packer, James M Boyett, Susan Blaney and 7 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Pediatric blood & cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006247 (A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.2field-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.

NCT00006247 phase1terminatednot on this map

A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors

TypeinterventionalSponsorPediatric Brain Tumor ConsortiumRan2000 to 2006Enrolled33ConditionsBrain and Central Nervous System TumorsArmssemaxanib
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 40 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Article
  6. Brainstem Glioma in Adults.Frontiers in oncology · 2016
    Review
  7. Article
  8. Molecular biology of pediatric brain tumors and impact on novel therapies.Current neurology and neuroscience reports · 2015
    Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Salvage chemotherapy for metastatic and recurrent ependymoma of childhood.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2009
    Review
  20. Article
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

17 authors at 12 institutions in 1 country.

Mark W KieranPediatric Neuro-Oncology Program, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. mark_kieran@dfci.harvard.edu
Jeffrey G Supko
Dana Wallace
Robert Fruscio
Tina Young Poussaint
Peter Phillips
Ian Pollack
Roger Packer
James M Boyett
Susan Blaney
Anu Banerjee
Russ Geyer
Henry Friedman
Stewart Goldman
Larry E Kun
Tobey Macdonald
Pediatric Brain Tumor Consortium
St. Jude Children's Research Hospital · USChildren's National · USHarvard University Press · USBaylor College of Medicine · USBoston Children's Hospital · USChildren's Hospital of Philadelphia · USChildren's Hospital of Pittsburgh · USDana-Farber Cancer Institute · USDuke University Hospital · USMemorial Hospital · USNeurological Surgery · USSeattle Children's Hospital · US

Funding

The Pediatric Brain Tumor Consortium (PBTC)U01CA081457 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI BOYETT, JAMES MILFORD · 1999 to 2013
$29.2M
NCI NIH HHS U01 CA081457NCI NIH HHS U01 CA81457
6 · The paper itself

Abstract

SU5416 is a novel small molecule tyrosine kinase inhibitor of the VEGF receptors 1 and 2. A phase I dose escalation study stratified by concurrent use (stratum II) or absence (stratum I) of enzyme-inducing anticonvulsant drugs was undertaken to estimate the maximum-tolerated dose (MTD) and to describe the toxicity profile of SU5416 in pediatric patients with refractory brain tumors. Dose escalations were conducted independently for stratum I starting at 110 mg/m(2) while stratum II started at 48 mg/m(2). Thirty-three eligible patients were treated on stratum I (n = 23) and stratum II (n = 10). Tumor types included 23 glial tumors, 4 neural tumors, 4 ependymomas, and 2 choroid plexus carcinomas. The MTD in stratum I was initially estimated to be 110 mg/m(2). The protocol was amended to determine the MTD after excluding transient AST elevation. Re-estimation of the MTD began at the 145 mg/m(2) dose level but due to development of SU5416 being stopped by the sponsor, the trial was closed before completion. The most serious drug-related toxicities were grade 3 liver enzyme abnormalities, arthralgia, and hallucinations. The plasma pharmacokinetics of SU5416 was not significantly affected by the concurrent administration of enzyme-inducing anticonvulsant drugs. Mean values of the total body clearance, apparent volume of distribution, and terminal phase half-life of SU5416 for the 19 patients in stratum I were 26.1 +/- 12.5 l/hr/m(2), 41.9 +/- 21.4 l/m(2), and 1.11 +/- 0.41 hr, respectively. The plasma pharmacokinetics of SU5416 in children was similar to previously reported findings in adult cancer patients. Prolonged disease stabilization was observed in 4 of 16 stratum I patients.

Indexed as

AdolescentAngiogenesis InhibitorsAnticonvulsantsArthralgiaCentral Nervous System NeoplasmsChildDrug InteractionsDrug Therapy, CombinationFemaleHallucinationsHumansIndolesLiverMaleMaximum Tolerated DoseProtein Kinase InhibitorsAngiogenesis InhibitorsAnticonvulsantsIndolesProtein Kinase InhibitorsPyrrolesReceptors, Vascular Endothelial Growth FactorSemaxinib

Identifiers

PMID19065567
PMCPMC2775441
OpenAlexW2036219324

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.