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

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.

Trial Details

NCT ID
NCT04655404
Phase
EARLY_PHASE1
Sponsor
Nationwide Children's Hospital
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Larotrectinib
  • Larotrectinib surgical
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Age: Patients ≤ 21 years of age (birth to 21 years of age) at the time of study enrollment will be eligible.
  • Diagnosis: Patients with newly-diagnosed high-grade (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors are documented in a CLI…
  • For sites that do not have CLIA-certified equivalent (certified laboratory) to assess NTRK fusion, testing will be conducted centrally at NCH. NTRK…
  • Disease Status: Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is…

For full eligibility, visit ClinicalTrials.gov.

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