Who can enter
- Children with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)
- All patients who were enrolled from the parent study CDRB436G2201
Goal
The goal of this study is to help collect information about the long-term outcomes of pediatric study participants who have been treated in clinical trials with dabrafenib, trametinib or the combination. This information will include the long-term effect on growth, development and general health of these study participants. Further, for those study participants currently on treatment in the parent protocol and would benefit from continued treatment (per investigator determination), this study will offer continued treatment with dabrafenib, trametinib or the combination, in accordance with the study participant’s parent protocol.
Background
Dabrafenib and trametinib are still in the study phase for children. Therefore, we are not sure how the drugs will work in children in the long term and what side effects can be expected and how serious they will be.
Dabrafenib (Tafinlar) and trametinib (Mekinist) have not yet been approved ("registered") by the Dutch government as medicines for children and adolescents under 18 years of age. Doctors cannot prescribe the drugs to patients of this age group. The drugs can only be administered in the context of a clinical study. For registration, research in that age group is required.
So far, approximately 10,000 (mostly adult) patients have been treated with dabrafenib (either as the only drug or together with trametinib). Dabrafenib and trametinib are registered for adults with certain types of lung cancer or melanoma. But the combination is not registered for adults with low grade or high grade glioma.