Lorlatinib for Brain Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers before starting lorlatinib. Also, avoid using lorlatinib with certain CYP3A substrates and P-glycoprotein substrates like digoxin.
How is the drug Lorlatinib unique for treating brain tumors?
Lorlatinib is unique because it is a third-generation drug that can effectively penetrate the blood-brain barrier (a protective layer around the brain) and target specific mutations in cancer cells, making it particularly effective for brain tumors that have spread from other areas, like lung cancer.12345
What data supports the effectiveness of the drug Lorlatinib for brain tumors?
Who Is on the Research Team?
Maryam Fouladi, MD
Principal Investigator
Nationwide Children's Hospital
Hamza Gorsi, MD
Principal Investigator
Children's Hospital of Michigan
Susan Chi, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for children newly diagnosed with high-grade gliomas, a type of brain tumor, that have specific genetic changes called ALK or ROS1 fusion. The exact eligibility criteria are not provided but typically include factors like age, health status, and the specifics of their cancer diagnosis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lorlatinib monotherapy for two 28-day cycles, followed by evaluation and potential continuation with chemotherapy or radiation therapy based on response
Maintenance Therapy
Participants continue with lorlatinib monotherapy or in combination with chemotherapy or post-radiation therapy, depending on age and response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lorlatinib
Lorlatinib is already approved in United States, European Union, Japan, Canada for the following indications:
- Metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
- Advanced non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
- Unresectable, advanced/recurrent non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
- Metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nationwide Children's Hospital
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University