Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow (NCT03363373)
A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
🩺 Plain-English Summary (8th-Grade Level)
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose. Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2
Who can join: Review the eligibility criteria below.
Location: Riley Hospital for Children — Indianapolis, Indiana
Age range: 1 Year
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Riley Hospital for Children — Indianapolis, Indiana
- Memorial Sloan Kettering Cancer Center — New York, New York
- The Hospital for Sick Children — Toronto,
- Rigshospitalet — Copenhagen,
- University Medical Center Hamburg-Eppendorf — Hamburg,
- Johannes Gutenberg-Universität — Mainz,
- University Hospital Regensburg — Regensburg,
- Hong Kong Children's Hospital — Hong Kong,
- Queen Mary Hospital — Hong Kong,
- Tata Memorial Centre — Mumbai,
- Giannina Gaslini Hospital — Genoa, Genoa
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Milan
- Ospedale Pediatrico Bambino Gesù — Rome,
- Hospital Sant Joan de Déu — Barcelona,
- Hospital Infantil Universitario Niño Jesús — Madrid,
- Hospital Universitario Virgen Del Rocío — Seville,
- Hospital Universitario y Politécnico La Fe — Valencia,
- The Royal Glasgow Children's Hospital — Glasgow,
- Leeds General Infirmary — Leeds,
- University Hospital Southampton — Southampton,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neuroblastoma
- Open-Label Study of 18F-mFBG for Imaging Neuroblastoma — Los Angeles, California
- Neuroblastoma Precision Trial — Los Angeles, California
- Neuroblastoma Maintenance Therapy Trial — Birmingham, Alabama
- A Study of N9 Chemotherapy in Children With Neuroblastoma — New York, New York
- A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma — San Francisco, California
Explore by condition: All Neuroblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.