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
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.
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.