Actively Recruiting
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
Led by Nationwide Children's Hospital · Updated on 2026-03-12
15
Participants Needed
18
Research Sites
512 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be between 12 months and 21 years old at enrollment.
- Newly diagnosed high-grade glioma including diffuse intrinsic pontine glioma with ALK or ROS-1 fusion.
- Histologically confirmed high-grade glioma by biopsy or resection.
- DIPG diagnosis requires tumor centered in the pons with diffuse involvement of at least two-thirds of the pons and WHO Grade 2-4 histopathology.
- All other high-grade gliomas must be WHO Grade 3 or 4.
- Patients with disseminated disease eligible only if chemotherapy (no craniospinal radiation) is planned.
- Patients with primary spinal tumors eligible if chemotherapy or focal radiation is planned.
- Karnofsky score ≥ 50% for patients older than 16 years; Lansky score ≥ 50 for patients 16 years or younger.
- No prior anti-cancer chemotherapy treatment.
- Adequate bone marrow, renal, liver, pulmonary, cardiac, and neurologic function as defined by specified laboratory and clinical criteria.
- Patients with controlled seizure disorder on anticonvulsants may enroll.
- Written informed consent and assent obtained as per guidelines.
You will not qualify if you...
- Pregnant or breastfeeding females.
- Patients not agreeing to effective contraception if of reproductive potential; females must use non-hormonal contraception during and for 6 months after treatment; males must use contraception during and for 3 months after treatment.
- Prior or current use of investigational drugs or other anti-cancer therapies.
- Active uncontrolled systemic bacterial, viral, or fungal infections.
- Prior solid organ transplantation.
- Malabsorption syndrome or conditions affecting oral drug absorption.
- Use of strong CYP3A4 inhibitors or inducers; moderate inducers should be avoided.
- Concomitant use of certain CYP3A substrates or P-glycoprotein substrates like digoxin.
- Inability to comply with safety monitoring requirements.
- History of severe psychiatric disorders, current suicidal ideation, or previous suicide attempts.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
Duke University Health System
Durham, North Carolina, United States, 27708
Not Yet 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
Not Yet Recruiting
8
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
9
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
10
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
11
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
12
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Not Yet Recruiting
13
Perth Children's Hospital
Perth, Western Australia, Australia, 6000
Not Yet Recruiting
14
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G1X8
Not Yet Recruiting
15
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A3J1
Not Yet Recruiting
16
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Not Yet Recruiting
17
Princess Máxima Center
Utrecht, Netherlands, 3720
Not Yet Recruiting
18
Starship Children's Hospital
Auckland, Grafton, New Zealand, 1023
Not Yet Recruiting
Research Team
K
Kelsey H Troyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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