Dabrafenib (low grade/high grade glioma)
Active, not recruiting
Who can enter
Children and adolescents with low grade glioma, or with high grade glioma in whom the disease has returned (relapse) or responded insufficiently to previous treatment (refractory), and with a documented BRAF V600 mutation
Age: 1 to 18 years
Goal
Goal
The goal of this study is to find out whether the combination of dabrafenib with trametinib is safe and effective in children and adolescents. We want to determine if and how children respond to the treatment, and which side effects may occur due to the treatment. In addition we will explore biomarkers: body substances that say something about the disease and about the effect of the treatment.
Background
Background
The BRAF V600-mutation is an aberration in the BRAF gene. This mutation is involved in the onset and maintenance of different types of cancer, including low grade and high grade glioma. The drugs dabrafenib and trametinib inhibit the protein produced by the BRAF gene. Therefore, these drugs may have a potential role in the treatment of low grade and high grade glioma.
The combination of dabrafenib and trametinib has already been approved (registered) for the treatment of adults with certain forms of melanoma or lung cancer carrying a BRAF V600 mutation. Dabrafenib alone (monotherapy) was well tolerated by children with high grade glioma in previous clinical studies. The effect of the combination of dabrafenib and trametinib in children is not known yet. Studies in adults suggest that this combination works better than treatment with dabrafenib alone.
In children and adolescents with low grade glioma we will compare the combination dabrafenib and trametinib with standard chemotherapy (vincristine and carboplatin). The drugs for this study are provided by Novartis.
Last reviewed
March 16, 2026
Study details
- Study details
Official title
Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)Cancer type
Low grade glioma
High grade glioma
Phase
2Maximum number of patients
142, of whom 5 are expected to participate in the NetherlandsStart date
January 9, 2018Status
Closed for inclusion, in finalisationLocal principal investigator
Dr. J. van der LugtSponsor
NovartisApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
EudraCT number 2015-004015-20
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.