Evidence map›Paper›PMID 31358541›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019

Antitumor Activity and Tolerability of hu14.18-IL2 with GMCSF and Isotretinoin in Recurrent or Refractory Neuroblastoma: A Children's Oncology Group Phase II Study.

Suzanne Shusterman, Arlene Naranjo, Collin Van Ryn, Jaquelyn A Hank, Marguerite T Parisi, Barry L Shulkin, Sabah Servaes, Wendy B London, Hiroyuki Shimada, Jacek Gan and 4 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

21 citing papers in PubMed, 32 citations in OpenAlex.

  1. Review
  2. Immunotherapeutic Strategies Targeting GD2-Expressing Malignancies.Advances in experimental medicine and biology · 2026
    Review
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  4. Article
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  14. Article
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  16. Anti-GD2 Antibodies Conjugated to IL15 and IL21 Mediate Potent Antitumor Cytotoxicity against Neuroblastoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Article
  17. Review
  18. Review
  19. Utilizing Immunocytokines for Cancer Therapy.Antibodies (Basel, Switzerland) · 2021
    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

14 authors at 9 institutions in 2 countries.

Suzanne ShustermanDana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, Massachusetts. Suzanne_Shusterman@dfci.harvard.edu.
Arlene NaranjoChildren's Oncology Group Statistics and Data Center, University of Florida, Gainesville, Florida.
Collin Van RynCoordinating Center for Biometric Research, University of Minnesota, Twin Cities, Minneapolis, Minnesota.
Jaquelyn A HankDepartments of Pediatrics, Human Oncology and Genetics and the University of Wisconsin, Madison, Wisconsin.
Marguerite T ParisiSeattle Children's Hospital and the University of Washington, Seattle, Washington.
Barry L ShulkinSt. Jude Children's Research Hospital and the University of Tennessee Health Science Center, University of Tennessee, Memphis, Tennessee.
Sabah ServaesChildren's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Wendy B LondonDana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, Massachusetts.
Hiroyuki ShimadaChildren's Hospital of Los Angeles and University of Southern California, Los Angeles, California.
Jacek GanDepartments of Pediatrics, Human Oncology and Genetics and the University of Wisconsin, Madison, Wisconsin.
Steven D GilliesProvenance Biopharmaceuticals, Carlisle, Massachusetts.
John M MarisChildren's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Julie R ParkSeattle Children's Hospital and the University of Washington, Seattle, Washington.
Paul M SondelDepartments of Pediatrics, Human Oncology and Genetics and the University of Wisconsin, Madison, Wisconsin.
University of Wisconsin–Madison · USChildren's Hospital of Philadelphia · USDana-Farber/Boston Children's Cancer and Blood Disorders Center · USSeattle Children's Hospital · USChildren's Oncology Group · CHscPharmaceuticals (United States) · USSt. Jude Children's Research Hospital · USUniversity of Minnesota · USUniversity of Southern California · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
University of Wisconsin Institute for Clinical and Translational ResearchUL1TR002373 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI ELIZABETH S BURNSIDE, Allan R. Brasier · 2017 to 2026
$75.9M
Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
Discovering mechanisms of neuroblastoma tumorigenesis to improve patient outcomesR35CA220500 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI JOHN M MARIS · 2017 to 2026
$8.7M
NRSA Training CoreTL1TR002375 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI Vivek Prabhakaran · 2017 to 2026
$8.4M
Enhancing Antibody-directed Innate Immunity to Improve Cancer OutcomeR35CA197078 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI SONDEL, PAUL M · 2015 to 2021
$6.4M
THE IMMUNOBIOLOGY OF HUMAN ANTILEUKEMIC LYMPHOCYTESR01CA032685 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI SONDEL, PAUL M · 1985 to 2014
$4.3M
T-Cell Independent Antitumor Mechanisms of CD40 LigationR01CA087025 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI SONDEL, PAUL M · 2002 to 2012
$2.4M
Institutional Clinical and Translational Science Award (UW-Madison)(TL1)TL1RR025013 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2007 to 2011
$1.1M
The Role of KIR and FcR Genotype in the Efficacy of mAb and IL2 ImmunotherapyR01CA166105 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI SONDEL, PAUL M · 2012 to 2014
$987k
NCATS NIH HHS TL1 TR002375NCATS NIH HHS UL1 TR000427NCATS NIH HHS UL1 TR002373NCI NIH HHS P30 CA086862NCI NIH HHS R01 CA032685NCI NIH HHS R01 CA087025NCI NIH HHS R01 CA166105NCI NIH HHS R35 CA197078NCI NIH HHS R35 CA220500NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCRR NIH HHS TL1 RR025013
6 · The paper itself

Abstract

purposeCombining anti-GD2 (disialoganglioside) mAb with GM-CSF, IL2, and isotretinoin is now FDA-approved for high-risk neuroblastoma minimal residual disease (MRD) therapy. The humanized anti-GD2 antibody conjugated to IL2 (hu14.18-IL2) has clinical activity in neuroblastoma and is more effective in neuroblastoma-bearing mice than antibody and cytokine given separately. We therefore evaluated the safety, tolerability, and antitumor activity of hu14.18-IL2 given with GM-CSF and isotretinoin in a schedule similar to standard MRD therapy. PATIENTS AND

methodsHu14.18-IL2 was given at the recommended phase II dose of 12 mg/m

resultsFifty-two patients with recurrent or refractory neuroblastoma were enrolled; 51 were evaluable for toxicity and 45 were evaluable for response. Four patients had unacceptable toxicities, well below the protocol-defined rule for tolerability. Other grade 3 and 4 nonhematologic toxicities were expected and reversible. No responses were seen in stratum 1 (

conclusionsHu14.18-IL2 given in combination with GM-CSF and isotretinoin is safe and tolerable. Patients with MIBG and/or bone marrow-only disease had a 16.1% response rate, confirming activity of the combination.

Indexed as

AdolescentAdultAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolDrug Administration ScheduleDrug Resistance, NeoplasmFeasibility StudiesFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansInterleukin-2IsotretinoinMaleNeoplasm Recurrence, LocalAntibodies, MonoclonalGranulocyte-Macrophage Colony-Stimulating FactorInterleukin-2Isotretinoinlorukafusp alfaRecombinant Proteinssargramostim

Identifiers

PMID31358541
PMCPMC6945765
OpenAlexW2965537076

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.