Evidence map›Paper›PMID 41299684›Full record

Trial reportJournal of hematology & oncology2025

Naxitamab plus stepped-up dosing of granulocyte-macrophage colony-stimulating factor for primary refractory high-risk neuroblastoma: results of a phase I/II trial.

Brian H Kushner, Shakeel Modak, Audrey Mauguen, Ellen M Basu, Stephen S Roberts, Nai-Kong V Cheung

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of hematology & oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01757626 (Phase I/II Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

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

NCT01757626 phase1 / phase2active not recruitingnot on this map

Phase I/II Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2012 to 2026Enrolled186ConditionsNeuroblastomaArmsHu3F8 With GM-CSF
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

6 authors.

Brian H KushnerDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA. kushnerb@mskcc.org.ORCID 0000-0002-8916-0697
Shakeel ModakDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Audrey MauguenDepartment of Biostatics and Epidemiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Ellen M BasuDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Stephen S RobertsDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.
Nai-Kong V CheungDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundWith high-risk neuroblastoma, post-induction metastases in bone marrow (BM)/bones confers a poor prognosis but can respond to anti-G

methodsCycles included GM-CSF and naxitamab infused (30-to-90 min) on days + 1, + 3, + 5. Naxitamab was dose-escalated in the trial's phase I portion and administered at 9 mg/kg/cycle (i.e., ~ 270 mg/m

resultsAmong 32 subjects, CR was noted in 24 (75%), including 12 by international criteria and 12 based on MIBG-avid sites with negative PET scans. BM CR was achieved in 22/23 with BM metastases. Of 29 patients with abnormal

conclusionsNaxitamb + GM-CSF is an attractive option for primary refractory osteomedullary disease, including in patients with a high disease burden. CLINICAL TRIALS REGISTRATION: Clinicaltrials.gov NCT01757626.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsGranulocyte-Macrophage Colony-Stimulating FactorNeuroblastomaChildChild, PreschoolFemaleHumansInfantMaleAntibodies, MonoclonalGranulocyte-Macrophage Colony-Stimulating FactorAnti-GD2 antibodyGM-CSFImmunotherapyNaxitamabNeuroblastoma

Identifiers

PMID41299684
PMCPMC12752410

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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.