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

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All participants will receive the study drug, larotrectinib. Patients may continue to take the study drug for up to 20 months if there aren't any side effects and their brain tumor does not get worse. Patients will be given a diary to write down the amount of study drugs (number of pills or amount of liquid) taken each day, the time taken and any missed doses. Treatment paths: After completing the first 2 cycles of larotrectinib, the next treatment received will depend on the response as seen on the MRI imaging and any changes seen in tumor size. If the tumor went away patients will continue to receive larotrectinib alone. If the tumor stayed the same or became smaller (shrink) patients will be able to remain on the research study and receive larotrectinib along with standard treatment for your brain tumor. Standard treatment may include chemotherapy or radiation therapy. If the tumor grew in size, patients will be removed from study treatment.


Child to Adult


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 to harbor an NTRK fusion. Patients must have had histologically verified high-grade glioma such as anaplastic astrocytoma, glioblastoma, or H3 K27-mutant diffuse midline glioma.

Please visit with your doctor for more detailed eligibility criteria.

Type of Study



Childrens Hospital Colorado

Principal Investigator
Photograph of Kathleen Dorris,  MD

Kathleen Dorris, MD

Study ID

Protocol Number: 21-2520

More information available at ClinicalTrials.gov: NCT04655404

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