Evidence map›Paper›PMID 22086404›Full record

Trial reportCancer2012

A phase 2 study of pegylated interferon α-2b (PEG-Intron(®)) in children with diffuse intrinsic pontine glioma.

Katherine Warren, Robyn Bent, Pamela L Wolters, Alisa Prager, Ryan Hanson, Roger Packer, Joanna Shih, Kevin Camphausen

Open access · bronzeAbstract readClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. A systematic review of ongoing clinical trials in optic pathway gliomas.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2020
    Pooled it
  2. Review
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  13. NK cell-based immunotherapies in Pediatric Oncology.Journal of pediatric hematology/oncology · 2015
    Review
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  17. Article
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  19. Review
  20. Brainstem glioma: a review.Current neurology and neuroscience reports · 2013
    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

8 authors at 2 institutions in 1 country.

Katherine WarrenPediatric Oncology Branch, National Cancer Institute, Bethesda, MD 20892, USA. warrenk@mail.nih.gov
Robyn Bent
Pamela L Wolters
Alisa Prager
Ryan Hanson
Roger Packer
Joanna Shih
Kevin Camphausen
National Cancer Institute · USChildren's National · US

Funding

Early Clinical Trials for Children with CNS TumorsZIABC011447 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WARREN, KATHERINE E · 2012 to 2019
$2.1M
Phase II Trial of PEG-Intron in Children with Diffuse Pontine GliomasZIABC010580 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WARREN, KATHERINE E · 2009 to 2019
$439k
Phase II Trial of PEG-Intron in Children with Diffuse Pontine GliomasZ01BC010580 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WARREN, KATHERINE E · 2005 to 2008
$257k
Intramural NIH HHS Z01 BC010580
6 · The paper itself

Abstract

backgroundInterferon-α is a cytokine that has demonstrated activity in patients with supratentorial gliomas, but its ideal dose and schedule of administration is unknown. Studies suggest that low-dose, continuous exposure is more efficacious than intermittent, high doses. The authors performed a phase 2 study of recombinant interferon α-2b with monomethoxy polyethylene glycol (PEG-Intron(®)) in children with diffuse intrinsic pontine glioma (DIPG), a population with dismal survival despite decades of clinical investigation. The primary objective was to compare 2-year survival with a historic cohort that received radiation therapy alone.

methodsPatients received weekly subcutaneous PEG-Intron(®) at a dose of 0.3 μg/kg beginning 2 to 10 weeks after the completion of radiation therapy until they developed disease progression. Patients were evaluated clinically and radiographically at regular intervals. Serum and urine were assayed for biomarkers before each cycle. Quality-of-life (QOL) evaluations were administered at baseline and before every other cycle of therapy to the parents of patients ages 6 to 18 years.

resultsThirty-two patients (median age, 5.3 years; range, 1.8-14.8 years) were enrolled and received a median of 7 cycles of therapy (range, from 1 cycle to ≥70 cycles). PEG-Intron(®) was well tolerated, and no decrease in QOL scores was noted in the subset of patients tested. The 2-year survival rate was 14%, which was not significantly improved compared with the historic cohort. However, the median time to progression was 7.8 months, which compared favorably with recent trials reporting a time to progression of 5 months in a similar population.

conclusionsAlthough low-dose PEG-Intron(®) therapy did not significantly improve 2-year survival in children with DIPG compared with an historic control population, it did delay the time to progression.

Indexed as

AdolescentAntineoplastic AgentsBrain Stem NeoplasmsChildChild, PreschoolCombined Modality TherapyDisease-Free SurvivalDrug Administration ScheduleFemaleHumansInfantInterferon-alphaInterferon alpha-2MalePolyethylene GlycolsQuality of LifeAntineoplastic AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID22086404
PMCPMC3290731
OpenAlexW1638173227

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.