Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
A Phase II Trial of Naxitamab plus Stepped-up Dosing of GM-CSF for Patients with High-Risk Neuroblastoma in First Complete Remission.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03033303 (Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma), which is not on this map. Cited by 3 papers.
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The trial behind it
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Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study
Who cites it
3 citing papers in PubMed.
- The role of immunotherapy in the treatment of neuroblastoma.Surgery today · 2026Review
- Article
- Cancer neuroscience: signaling pathways and new therapeutic strategies for cancer.Signal transduction and targeted therapy · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
purposeNaxitamab is a humanized form of the murine anti-GD2 mAb 3F8. In an international trial, naxitamab + GM-CSF was effective against chemoresistant high-risk neuroblastoma (HR-NB), leading to approval by the FDA. We now report results with patients in first complete remission (CR). PATIENTS AND
methodsThe primary objective of this phase II protocol 16-1643 (Clinicaltrials.gov NCT03033303) was to assess event-free survival of patients with HR-NB in first CR treated with naxitamab + GM-CSF plus isotretinoin. HR-NB was defined as MYCN-amplified disease (any age) or metastatic disease at age >18 months. Cycles of immunotherapy were administered monthly up to five cycles and comprised (i) subcutaneously administered priming doses of GM-CSF 250 μg/m2/day on days -4 to -0 (Wednesday-Sunday), followed by a step-up to 500 μg/m2/day on days +1 to +5 (Monday-Friday) and (ii) naxitamab infused intravenously (30-90") on days +1, +3, and +5 (Monday-Wednesday-Friday, i.e., three doses/cycle). The dosage of naxitamab was 3 mg/kg/infusion (9 mg/kg/cycle, i.e., ∼270 mg/m2/cycle). The dosage of isotretinoin was 160 mg/m2/day started after cycle 2, ×14 days/course, and ×6 courses.
resultsFifty-nine patients with HR-NB (53 stage 4, 6 stage 3) were enrolled from February 2017 to July 2020. At 36 months, event-free/overall survival rates were 73%/93%, but 50 of 59 patients received after protocol treatment (vaccine and/or difluoromethylornithine). Six of 18 relapses were isolated in the central nervous system. Longer time from diagnosis to enrollment was a significantly adverse prognostic factor (P = 0.04). Twenty-one of 59 patients took no isotretinoin. Treatment was tolerable allowing outpatient administration.
conclusionsNaxitamab + GM-CSF is a good option to consolidate first CR of patients with HR-NB, including those who did not undergo autologous stem-cell transplantation. Efforts to prevent central nervous system relapse are warranted.
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