There are 2 groups in this trial. Children and young people who have:
The trial team need about 40 children and young people to join this group. Everyone will take dabrafenib and trametinib.
2 out of every 3 children and young people will be in the dabrafenib and trametinib group.
Dabrafenib and trametinib
You have dabrafenib as a capsule or a liquid. You take it twice a day. Your doctor will tell you how many capsules or how much liquid to take.
You have trametinib as a tablet or a liquid. You take it twice a day. Your doctor will tell you how many tablets or how much liquid to take.
You continue taking dabrafenib and trametinib as long as it is helping and the side effects aren’t too bad.
Carboplatin and vincristine
- once a week for 10 weeks
- followed by no treatment for 2 weeks
- followed by maintenance treatment
You have maintenance treatment:
- once a week for 4 weeks
- followed by no treatment for 2 weeks
Each 6 week period is called a
cycle of treatment. You have 8 cycles of maintenance treatment.
After you finish chemotherapy, or if your glioma gets worse, you might be able to start taking dabrafenib and trametinib. Your doctor or a member of the trial team will talk to you about this.
Questionnaires
Children and young people taking dabrafenib and trametinib as a liquid fill in a questionnaire during the 1st week and 5th week of treatment. This questionnaire is about the taste of the liquid.
Everyone who has a slow growing (low grade) glioma will fill in a questionnaire:
- every month for 3 months
- then every 8 weeks for about 9 months
- then every 16 weeks while you are having treatment
Samples
When you agree to join the trial, the team will ask for a small piece of glioma tissue from when you had your surgery. If this isn’t available, you must agree to have a small piece of glioma tissue (biopsy) taken. They use this sample to confirm your glioma has the change (mutation) in the BRAF V600 gene.
During the trial if your glioma gets worse and you have surgery to remove it the team will ask for a small piece of the glioma tissue. They will use this to learn:
- why the treatment has stopped working
- more about how dabrafenib and trametinib works
- why dabrafenib and trametinib works better for some people and not others
The trial team will take extra blood samples from those who are taking dabrafenib and trametinib. They will use these to find out what happens to these 2 drugs in the body.
They will also ask for extra blood samples at the start of treatment and if your glioma gets worse. You don’t have to agree to these samples being taken. You can still take part in the trial.
Researchers will use the blood samples to look for substances (biomarkers) in them that could help identify who might benefit from this treatment in the future.