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| Diagnosis | High Grade Glioma | Study Status | Open |
| Phase | II |
| Age | Child, Adult - (up to 21 Years) | Randomisation | NO |
| Line of treatment | First line treatment |
| Routes of Treatment Administration | Oral |
| Last Posted Update | 2024-10-10 |
| ClinicalTrials.gov # | NCT04655404 |
International Sponsor
Nationwide Children's HospitalPrincipal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
The Hospital for Sick Children - Dr. Uri TaboriCentres
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Study Description
(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )
Recent research shows that a new oral tablet drug, larotrectinib, has produced promising results by shrinking some solid tumours that have an abnormal or mutated NTRK gene in adults and children.
High grade gliomas (HGG) are fast growing, aggressive brain cancers and if they recur after initial treatment, there are no effective treatment options. This study will investigate if larotrectinib alone as well as Larotrectinib in combination with chemotherapy or radiotherapy can be of benefit in children with high grade gliomas with the mutated NTRK gene. This international trial will study how well the drug is tolerated and its effectiveness to shrink these tumours when used alone or when given with standard chemotherapy or after radiation.
Inclusion Criteria
(As seen on the Australian & New Zealand Childrens Haematology/Oncology Group website - https://anzchog.org/clinic-trails/connect-1903-a-pilot-and-surgical-study-of-larotrectinib-for-treatment-of-children-with-newly-diagnosed-high-grade-glioma-with-ntrk-fusion/ )
- Patient must be 21 years old or younger and newly diagnosed with high grade glioma (HGG)
- The tumour must have a genetic anomaly called an NTRK fusion for the patient to qualify
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
