Evidence map›Paper›PMID 25531693›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2015

Phase 1 study of intratumoral Pexa-Vec (JX-594), an oncolytic and immunotherapeutic vaccinia virus, in pediatric cancer patients.

Timothy P Cripe, Minhtran C Ngo, James I Geller, Chrystal U Louis, Mark A Currier, John M Racadio, Alexander J Towbin, Cliona M Rooney, Adina Pelusio, Anne Moon and 5 more

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

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03792724 (Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors), which is not on this map. Cited by 95 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 1 pooled it
9.1field-weighted citation impact, top 2% 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.

NCT03792724 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2019 to 2023Enrolled32ConditionsNeoplasmsArmsUrelumab + Nivolumab
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 1 synthesis or guideline pooled it, 158 citations in OpenAlex.

  1. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Cells · 2025
    Article
  8. Review
  9. Review
  10. Review
  11. Translation of oncolytic viruses in sarcoma.Molecular therapy. Oncology · 2024
    Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

35 more citing papers are in PubMed but not listed here.

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

15 authors at 7 institutions in 3 countries.

Timothy P CripeNationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA.
Minhtran C NgoTexas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
James I GellerCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA.
Chrystal U LouisTexas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
Mark A CurrierNationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA.
John M RacadioCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA.
Alexander J TowbinCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA.
Cliona M RooneyTexas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
Adina PelusioSillaJen, Inc, Seoul, South Korea.
Anne MoonSillaJen, Inc, Seoul, South Korea.
Tae-Ho HwangSillaJen, Inc, Seoul, South Korea.
James M BurkeSillaJen, Inc, Seoul, South Korea.
John C BellOttawa Health Research Institute and University of Ottawa, Ottawa, Ontario, Canada.
David H KirnSillaJen, Inc, Seoul, South Korea.
Caroline J BreitbachSillaJen, Inc, Seoul, South Korea.
SillaJen (South Korea) · KRNationwide Children's Hospital · USTexas Children's Hospital · USUniversity of Cincinnati · USBaylor College of Medicine · USCincinnati Children's Hospital Medical Center · USUniversity of Ottawa · CA

Funding

Oncolytic HSV Therapy in Immunocompetent Sarcoma ModelsR01CA114004 · NCI · CINCINNATI CHILDRENS HOSP MED CTR · PI CRIPE, TIMOTHY P · 2006 to 2010
$1.3M
NCI NIH HHS R01 CA114004
6 · The paper itself

Abstract

Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic and immunotherapeutic vaccinia virus designed to destroy cancer cells through viral lysis and induction of granulocyte-macrophage colony-stimulating factor (GM-CSF)-driven tumor-specific immunity. Pexa-Vec has undergone phase 1 and 2 testing alone and in combination with other therapies in adult patients, via both intratumoral and intravenous administration routes. We sought to determine the safety of intratumoral administration in pediatric patients. In a dose-escalation study using either 10(6) or 10(7) plaque-forming units per kilogram, we performed one-time injections in up to three tumor sites in five pediatric patients and two injections in one patient. Ages at study entry ranged from 4 to 21 years, and their cancer diagnoses included neuroblastoma, hepatocellular carcinoma, and Ewing sarcoma. All toxicities were ≤ grade 3. The most common side effects were sinus fever and sinus tachycardia. All three patients at the higher dose developed asymptomatic grade 1 treatment-related skin pustules that resolved within 3-4 weeks. One patient showed imaging evidence suggestive of antitumor biological activity. The two patients tested for cellular immunoreactivity to vaccinia antigens showed strong responses. Overall, our study suggests Pexa-Vec is safe to administer to pediatric patients by intratumoral administration and could be studied further in this patient population.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsGamma RaysAdolescentBone NeoplasmsBrain NeoplasmsCancer VaccinesCarcinoma, HepatocellularChildChild, PreschoolFemaleGenetic VectorsHumansImmunotherapyInjections, IntralesionalLiver NeoplasmsMaleCancer Vaccines

Identifiers

PMID25531693
PMCPMC4351466
OpenAlexW1988967544

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.