RecruitingEarly Phase 1NCT06333899

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

Sponsor

Nationwide Children's Hospital

Enrollment

15 participants

Start Date

Aug 3, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Glioblastoma Multiforme High Grade Glioma Diffuse Intrinsic Pontine Glioma Anaplastic Astrocytoma Infant Type Hemispheric Glioma WHO Grade III Glioma WHO Grade IV Glioma Diffuse Midline Glioma, H3K27-altered

Summary

The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.

Eligibility

Min Age: 1 YearMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called lorlatinib in children and young adults who have been newly diagnosed with a high-grade brain tumor (including a particularly serious type called DIPG) that has a specific genetic change — either an ALK or ROS-1 fusion. Lorlatinib is a targeted therapy that may work against these genetic mutations. **You may be eligible if...** - You are between 12 months and 21 years old - You have been newly diagnosed with a high-grade brain tumor (grade 3 or 4) or DIPG - Your tumor has been confirmed to have an ALK or ROS-1 gene fusion - Your diagnosis has been confirmed by biopsy or surgery **You may NOT be eligible if...** - Your tumor does not have an ALK or ROS-1 gene fusion - You have already received certain prior treatments for this tumor - You are under 12 months or over 21 years old 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

DRUGLorlatinib

Continue maintenance monotherapy for total 12 cycles

DRUGLorlatinib with chemotherapy1

Continue lorlatinib with BABY-POG chemotherapy backbone for 72 weeks

DRUGLorlatinib with chemotherapy 2

Continue lorlatinib with HIT-SKK chemotherapy backbone for 42 weeks

DRUGLorlatinib post Radiation

Continue lorlatinib monotherapy 28 days post completion of radiation therapy for 12 cycles

Locations(18)

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

Princess Máxima Center

Utrecht, Netherlands

Starship Children's Hospital

Auckland, Grafton, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06333899

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