Go to Health Care Provider version
| Diagnosis | Low Grade Glioma, relapsed or refractory high grade glioma with BRAF V600 mutation | Study Status | Closed to enrollment |
| Phase | II |
| Age | Child - (12 Months to 17 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Dabrafenib and trametinib (oral).
Other drugs are given as usually administered for low grade glioma therapy. |
| Last Posted Update | 2022-04-25 |
| ClinicalTrials.gov # | NCT02684058 |
International Sponsor
Novartis PharmaceuticalsPrincipal Investigators for Canadian Sites
BC Children’s Hospital – Dr. Juliette Hukin
The Hospital for Sick Children - Dr. Uri Tabori
Montreal Children's Hospital – Dr. Catherine Vézina
CHU Ste-Justine – Dr. Sébastien Perreault
Centres
Medical contact
Rebecca Deyell
Social worker/patient navigator contact
Ilana Katz
Clinical research contact
Hem/Onc/BMT Clinical Trials Unit
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
Study Description
(Translated from summary in French available on u-link.eu for the same study)
Gliomas are the most common brain tumors in children. They are classified into two groups: low-grade gliomas common in younger people and high-grade malignant gliomas that affect older children or adolescents. Genetic studies of these tumors have made it possible to highlight specific mutations which open the opportunity to new therapeutic avenues when standard treatments have not been effective.
In this protocol a combination of two drugs is used:
- Dabrafenib blocks a cellular process necessary for cell proliferation (it is a BRAF inhibitor)
- Trametinib blocks another process necessary for cell proliferation (it is a MEK inhibitor)
This study explores the efficacy and tolerance of these two new medications taken together.
Their association is studied on the two groups of glioma as follows:
- For children with high-grade glioma who have not responded to the standard treatment, the two molecules are taken orally every day.
- For children with low-grade glioma, the children are divided into 2 groups by drawing lots (randomization):
- The first group receives the two molecules orally every day.
- The second group receives classical chemotherapy (vincristine and carboplatin) according to standard of care. If the disease progresses despite these treatments, patient will be able to receive the two molecules tested
- In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study
Inclusion Criteria
(Translated from summary in French available on u-link.eu for the same study)
- Child aged 1 to 18
- Low or high grade glioma to whom standard treatments have not produced a sufficient response or who have relapsed.
- In all cases the tumour will need to have a marker called BRAF V600 for the child to be considered for this study
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
