CONNECT 1903 - Larotrectinib for Children with Newly-Diagnosed HGG with NTRK Fusion

Purpose of this Study

We want to find out if a study drug called larotrectinib is an effective treatment for brain tumors in children and young adults. We want to learn how well it works to shrink brain tumors when used alone or when given with standard chemotherapy or after radiation therapy.

Who Can Participate?

Eligibility

Children and young adults ages 1-21 who have a newly diagnosed high-grade glioma, including diffuse intrinsic pontine gliomas (DIPG), that has been tested to confirm the presence of an abnormal NTRK gene in the tumor. For more information about who can participate in this study, please contact the study team at 919-684-5301.

Age Range

0-21

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join the study, you or your child will:
  • Take the study drug (larotrectinib) by mouth as either a pill or liquid
  • Be evaluated by the study doctor after 2 cycles of the study drug (one cycle equals 28 days) to determine the next course of treatment
  • Continue to take the study drug on its own, or combined with standard chemotherapy, or on its own following radiation treatment based on the study doctor's evaluation after the first 2 cycles
The length of treatment in the study will vary and depends on how well you or your child are doing and which treatment the doctor thinks is best for you or your child. You or your child will visit our clinic at least every 28 days to see the study doctor. Visits might be more frequent depending on treatment and how you/your child are feeling. There is also a surgical cohort of the study where tumor samples and blood samples will be collected and sent to researchers to determine if larotrectinib is found in the tumor and how much is in the blood.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

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

Principal Investigator

Daniel
Landi

Protocol Number

PRO00104689

NCT ID

NCT04655404

Phase

Pilot

Enrollment Status

Open to Enrollment
ClinicalTrials.gov