Actively Recruiting
A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion
Led by Nationwide Children's Hospital · Updated on 2026-03-18
15
Participants Needed
21
Research Sites
816 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 21 years old or younger at enrollment.
- Newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) with tumor confirmed to have NTRK fusion by certified lab testing.
- Histologically verified high-grade glioma such as anaplastic astrocytoma, glioblastoma, or H3 K27-mutant diffuse midline glioma.
- Patients with disseminated DIPG or HGG eligible only if receiving chemotherapy without craniospinal radiation.
- Patients with primary spinal tumors eligible if receiving chemotherapy or focal radiation without craniospinal radiation.
- Surgical cohort: patients with prior biopsy and planned definitive surgery, excluding DIPG.
- Karnofsky performance score ≥50% for patients older than 16 years; Lansky score ≥50 for patients 16 years or younger.
- No prior anti-cancer chemotherapy; prior corticosteroid use allowed.
- Adequate bone marrow, renal, liver, pulmonary, and neurologic function as defined.
- Written informed consent/assent obtained per institutional guidelines.
You will not qualify if you...
- Pregnant or breast-feeding women; pregnancy tests required for post-menarchal girls.
- Use of effective contraception required for males and females of reproductive potential.
- Prior or current use of other investigational drugs.
- Prior or current treatment with other anti-cancer agents including chemotherapy, immunotherapy, monoclonal antibodies, biologics, or targeted therapy.
- Active, uncontrolled systemic bacterial, viral, or fungal infection.
- Prior solid organ transplantation.
- Malabsorption syndrome or conditions affecting oral drug absorption.
- Treatment with strong CYP3A4 inhibitors or inducers from 7 days before enrollment through study end.
- Inability to comply with safety monitoring requirements as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Withdrawn
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Duke University Health System
Durham, North Carolina, United States, 27708
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Nationwide Children's Hospital
Columbus, Ohio, United States, 43235
Actively Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
10
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
11
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
12
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
13
Perth Children's Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
14
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G1X8
Actively Recruiting
15
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
16
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
17
University Medical Center Augsburg
Augsburg, Germany
Actively Recruiting
18
University Hospital Berlin
Berlin, Germany
Actively Recruiting
19
University Hospital Koln
Cologne, Germany
Actively Recruiting
20
University Medical Center Gottingen
Göttingen, Germany
Actively Recruiting
21
Starship Children's Hospital
Auckland, Grafton, New Zealand, 1023
Actively Recruiting
Research Team
K
Kelsey H Troyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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