🏛️ Verified NIH Record • Updated 2026-03-16

A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion (NCT04655404)

A Pilot and Surgical Study of Larotrectinib for Treatment of Children With Newly-Diagnosed High-Grade Glioma With NTRK Fusion

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Nationwide Children's Hospital

🩺 Plain-English Summary (8th-Grade Level)

This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.

Who can join: Review the eligibility criteria below.

Location: Children's Hospital Colorado — Aurora, Colorado

Age range: Not specified to 21 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (21 Sites)

  • Children's Hospital Colorado — Aurora, Colorado
  • Children's National Medical Center — Washington D.C., District of Columbia
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • Duke University Health System — Durham, North Carolina
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
  • Nationwide Children's Hospital — Columbus, Ohio
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
  • Texas Children's Hospital — Houston, Texas
  • Seattle Children's Hospital — Seattle, Washington
  • Sydney Children's Hospital — Randwick, New South Wales
  • Queensland Children's Hospital — South Brisbane, Queensland
  • Perth Children's Hospital — Perth, Western Australia
  • The Hospital for Sick Children (SickKids) — Toronto, Ontario
  • Montreal Children's Hospital — Montreal, Quebec
  • Hopp Children's Cancer Center at NCT Heidelberg (KiTZ) — Heidelberg, Baden-Wurttemberg
  • University Medical Center Augsburg — Augsburg,
  • University Hospital Berlin — Berlin,
  • University Hospital Koln — Cologne,
  • University Medical Center Gottingen — Göttingen,
  • Starship Children's Hospital — Auckland, Grafton

📞 Contact the Study Coordinator

Phone: (614) 722-3284

Email: kelsey.troyer@nationwidechildrens.org

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

💰 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.

💡 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.
🏛️ View Official NIH Record ↗