RecruitingEarly Phase 1NCT04655404

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

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


Sponsor

Nationwide Children's Hospital

Enrollment

15 participants

Start Date

Apr 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This pilot trial tests whether larotrectinib — a drug that targets a specific genetic change called an NTRK fusion — can work in children and young adults (up to age 21) who have been newly diagnosed with high-grade brain tumors (including aggressive gliomas and brain stem tumors) that contain this genetic abnormality. **You may be eligible if...** - You are 21 years old or younger - You have been newly diagnosed with a high-grade brain tumor (such as glioblastoma, anaplastic astrocytoma, DIPG, or H3 K27-mutant diffuse midline glioma) - Your tumor has been confirmed to have an NTRK fusion gene alteration through certified laboratory testing **You may NOT be eligible if...** - Your tumor does not have an NTRK fusion - You have disseminated disease and are planned to receive radiation to the entire spine - You cannot participate due to health or other reasons as determined by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLarotrectinib

1. Larotrectinib monotherapy x2 cycles followed by disease evaluation 2. Larotrectinib with or without chemotherapy backbone

PROCEDURELarotrectinib surgical

1. Surgical cohort: Larotrectinib x 3-5 days prior to definitive surgery followed by Larotrectinib monotherapy x2 cycles followed by disease evaluation 2. Larotrectinib with or without chemotherapy backbone


Locations(21)

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Duke University Health System

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)

Heidelberg, Baden-Wurttemberg, Germany

University Medical Center Augsburg

Augsburg, Germany

University Hospital Berlin

Berlin, Germany

University Hospital Koln

Cologne, Germany

University Medical Center Gottingen

Göttingen, Germany

Starship Children's Hospital

Auckland, Grafton, New Zealand

View Full Details on ClinicalTrials.gov

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NCT04655404


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