๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-10

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma (NCT05489887)

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Giselle Sholler

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

Who can join: Review the eligibility criteria below.

Location: University of Alabama/Children's of Alabama โ€” Birmingham, Alabama

Age range: 12 Months to 21 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

  • University of Alabama/Children's of Alabama โ€” Birmingham, Alabama
  • Arkansas Children's Hospital โ€” Little Rock, Arkansas
  • UCSF Benioff Children's Hospital Oakland โ€” Oakland, California
  • Rady Children's Hospital โ€” San Diego, California
  • Connecticut Children's Hospital โ€” Hartford, Connecticut
  • University of Florida โ€” Gainesville, Florida
  • Nicklaus Children's Hospital โ€” Miami, Florida
  • Arnold Palmer Hospital for Children โ€” Orlando, Florida
  • Augusta University Health โ€” Augusta, Georgia
  • Kapiolani Medical Center for Women and Children โ€” Honolulu, Hawaii
  • Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine โ€” Louisville, Kentucky
  • Children's Hospital and Clinics of Minnesota โ€” Minneapolis, Minnesota
  • Cardinal Glennon Children's Hospital โ€” St Louis, Missouri
  • Levine Children's Hospital โ€” Charlotte, North Carolina
  • Duke University โ€” Durham, North Carolina
  • Wake Forest University Health Sciences โ€” Winston-Salem, North Carolina
  • Randall Children's Hospital โ€” Portland, Oregon
  • Penn State Milton S. Hershey Medical Center and Children's Hospital โ€” Hershey, Pennsylvania
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Dell Children's Blood and Cancer Center โ€” Austin, Texas
  • Virginia Commonwealth University โ€” Richmond, Virginia
  • GRAACC Hospital โ€” Sรฃo Paulo, Sรฃo Paulo
  • UHC Sainte-Justine โ€” Montreal, Quebec
  • CHUQ โ€” Quรฉbec, Quebec
  • CIUSSS de l'Estrie-CHUS โ€” Sherbrooke, Quebec

๐Ÿ“ž Contact the Study Coordinator

Phone: (717) 531-0003

Email: BCCEnroll@pennstatehealth.psu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All Neuroblastoma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—