Evidence map›Paper›PMID 24309609›Full record

Trial reportJournal of pediatric hematology/oncology2014

Pediatric phase II trials of poly-ICLC in the management of newly diagnosed and recurrent brain tumors.

Lisa L R Hartman, John R Crawford, Milan T Makale, Mehrzad Milburn, Shweta Joshi, Andres M Salazar, Beth Hasenauer, Scott R VandenBerg, Tobey J MacDonald, Donald L Durden

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

Trial report in Journal of pediatric hematology/oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03262103 (Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol®), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
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.

NCT03262103 phase1completednot on this mapstarted 2017, after this paper: background citation

Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy

TypeinterventionalSponsorAshutosh Kumar TewariRan2017 to 2022Enrolled13ConditionsProstate CancerArmsIntratumoral (IT) Poly ICLC 0.5 mg, Intratumoral (IT) Poly ICLC 1.0 mg, Intramuscular (IM) Poly ICLC, Radical Prostatectomy
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Immunotherapy for pediatric low-grade gliomas.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Review
  4. Low-grade glioma in children with neurofibromatosis type 1: surveillance, treatment indications, management, and future directions.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2024
    Review
  5. Article
  6. Review
  7. Review
  8. Epigenetic state determines inflammatory sensing in neuroblastoma.Proceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  9. Review
  10. Tumour immune landscape of paediatric high-grade gliomas.Brain : a journal of neurology · 2021
    Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Toward RNA nanoparticle vaccines: synergizing RNA and inorganic nanoparticles to achieve immunopotentiation.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2017
    Review
  18. Recent advances and future of immunotherapy for glioblastoma.Expert opinion on biological therapy · 2016
    Review
  19. Review
  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

10 authors at 6 institutions in 1 country.

Lisa L R HartmanDepartments of *Pediatrics §Neuro-oncology #Pathology (Division of Neuropathology), Moores UCSD Cancer Center †Pediatrics ‡Neurosciences/Pediatrics, Rady Children's Hospital, University of California San Diego, La Jolla, CA ∥Oncovir Inc. ¶Children's Oncology Group, Childrens Hospital of Orange County, Orange, CA **Department of Pediatrics, Emory University, AFLAC Cancer Center, Children's Healthcare of Atlanta, Atlanta, GA.
John R Crawford
Milan T Makale
Mehrzad Milburn
Shweta Joshi
Andres M Salazar
Beth Hasenauer
Scott R VandenBerg
Tobey J MacDonald
Donald L Durden
University of California, San Diego · USChildren's Oncology Group · USEmory University · USPediatrics and Genetics · USRady Children's Hospital-San Diego · USUniversity of California, Irvine · US

Funding

VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DIANE M SIMEONE · 1985 to 2026
$124.9M
UCSD Cancer Center Training Program in Drug DevelopmentT32CA121938 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Michael Bouvet, Dwayne G. Stupack · 2006 to 2026
$10.3M
NCI NIH HHS 5 P30 CA23100-21NCI NIH HHS P30 CA023100NCI NIH HHS R01 CA75737NCI NIH HHS T32 CA121938NCI NIH HHS T32CA121938
6 · The paper itself

Abstract

Brain tumors are the most common solid tumor diagnosed in childhood that account for significant morbidity and mortality. New therapies are urgently needed; hence, we conducted the first ever prospective open-label phase II trials of the biological response modifier, poly-ICLC, in children with brain tumors. Poly-ICLC is a synthetic double-stranded RNA that has direct antiviral, antineoplastic, and immune adjuvant effects. A total of 47 children representing a variety of brain tumor histopathologic subtypes were treated with poly-ICLC. On the basis of the results of the initial phase II trial, an expanded prospective phase II trial in low-grade glioma (LGG) has been initiated. MRI was used to acquire volume-based measures of tumor response. No dose-limiting toxicities have been observed. In the initial study 3 of 12 subjects with progressive high-grade gliomas (HGGs) responded, and 2 of 4 children with progressive LGG experienced stable disease for 18 to 24 months. In the follow-up LGG phase II study, 2 of 5 LGG patients were stable over 18 months, with 1 stable for 6 months. Overall 5 of 10 LGG patients have responded. On the basis of low toxicity and the promising LGG response, poly-ICLC may be effective for childhood LGG, and the results justify biomarker studies for personalization of poly-ICLC as a single agent or adjuvant.

Indexed as

AdolescentAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarboxymethylcellulose SodiumChildChild, PreschoolDose-Response Relationship, DrugFemaleGliomaHumansInfantMagnetic Resonance AngiographyMaleNeoplasm GradingPoly I-CAntineoplastic AgentsCarboxymethylcellulose SodiumPoly I-Cpoly ICLCPolylysine

Identifiers

PMID24309609
PMCPMC4356196
OpenAlexW2009052042

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.