๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-24

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma (NCT06540963)

Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

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

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

The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing

Who can join: Review the eligibility criteria below.

Location: Arkansas Children's Hospital โ€” Little Rock, Arkansas

Age range: 1 Year 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 (12 Sites)

  • Arkansas Children's Hospital โ€” Little Rock, Arkansas
  • Connecticut Children's Hospital โ€” Hartford, Connecticut
  • Nicklaus Children's Hospital โ€” Miami, Florida
  • Arnold Palmer Hospital for Children โ€” Orlando, Florida
  • Kapiolani Medical Center for Women and Children โ€” Honolulu, Hawaii
  • Cardinal Glennon Children's Medical Center โ€” St Louis, Missouri
  • Duke University โ€” Durham, North Carolina
  • Randall Children's Hospital โ€” Portland, Oregon
  • Penn State Milton S. Hershey Medical Center and Children's Hospital โ€” Hershey, Pennsylvania
  • Monroe Carrell Jr. Children's Hospital at Vanderbilt โ€” Nashville, Tennessee
  • Dell Children's Blood and Cancer Center โ€” Austin, Texas
  • Children's Medical Center โ€” Dallas, Texas

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†—