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| Diagnosis | Low Grade Glioma, Neurofibromatosis Type 1 | Study Status | Open |
| Phase | III |
| Age | 2 Years to 21 Years | Randomisation | YES |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Active Comparator: Arm I (carboplatin, vincristine)
Experimental: Arm II (selumetinib sulfate) |
| Last Posted Update | 2024-08-21 |
| ClinicalTrials.gov # | NCT03871257 |
International Sponsor
National Cancer Institute (NCI)Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Uri Tabori
Montreal Children's Hospital - Dr. Stephanie Mourad
CHU Ste Justine - Dr. Monia Marzouki
CHU Sherbrooke - Dr. Josee Brossard
IWK Health Centre - Dr. Criag ErkerCentres
Medical contact
Clinical Research Unit
Social worker/patient navigator contact
Clinical Research Unit
Clinical research contact
Stephanie Badour
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques
Medical contact
Dr. Josee Brossard
Social worker/patient navigator contact
Please Contact Site Directly
Clinical research contact
Please Contact Site Directly
Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez
Dr. Ketan Kulkarni
Social worker/patient navigator contact
Rhonda Brophy
Clinical research contact
Tina Bocking
Study Description
This study is looking at a new drug called selumetinib to see if it works as well as (or better than) the usual treatment (drugs called carboplatin/vincristine) for children with a type of brain tumor called low grade glioma. This study is also checking if selumetinib is better for helping improve vision for children with these tumors. Selumetinib works by blocking a substance called an enzyme that the tumor cells need to grow, which can help kill them. The regular treatment uses different drugs that stop tumor cells from growing in different ways. This study will compare to see which method is better.
Inclusion Criteria
- Patients must be >= 2 years and =< 21 years at the time of enrollment
- Patients must have neurofibromatosis type 1 (NF1), newly diagnosed or have previously diagnosed NF-1 associated LGG that has not been treated with any modality other than surgery
- Additional inclusion criteria applies for patients with optic pathway gliomas, if applicable
- Patient must meet all of the bloodwork and organ function requirements outlined in the study
- Patients with a known seizure disorder should be stable and should have not experienced a significant increase in seizure frequency within 2 weeks prior to enrollment
- Patients must have an adequate performance status
- Patients must have the ability to swallow whole capsules
- All patients and/or their parents or legal guardians must sign a written informed consent.
Other inclusion and exclusion criteria applies and will be discussed with you by the study team.
