About this study
Children and young adults with low-grade glioma often do well with treatment. But many need medicine for a long time to keep the tumor from growing. Some tumors have a change in a gene called BRAF V600. Medicines called dabrafenib and trametinib can help treat these tumors. Doctors do not know the best way to stop these medicines after they have worked. Stopping too soon could allow the tumor to grow again. Staying on treatment longer may cause more side effects.
This study is for children and young adults with low-grade gliomas that have a BRAF V600 gene change. The study includes patients with newly diagnosed tumors and those whose tumors came back or got worse after treatment ended.
Everyone in the study receives dabrafenib and trametinib for 12– 24 treatment cycles if the medicines continue to work and side effects stay manageable.
Next, patients will be assigned at random into 1 of 2 groups. One group will stop taking both medicines. The other group will slowly lower the dose over about 6 more months before stopping.
During the study, patients have regular clinic visits, MRI scans, blood tests, heart tests, and other health checks. Some may also choose to give extra blood or spinal fluid samples for research.
Researchers will watch patients closely for up to 5 years after treatment ends. They want to see how long the tumors stay under control and whether they start to grow again. They will also study side effects, quality of life, and how well each approach works for people from different racial and ethnic groups.
Researchers hope this study will show whether it is better to stop treatment all at once or lower the dose over time. What they learn may help doctors reduce side effects while continuing to control low-grade gliomas with BRAF V600 gene changes.
Eligibility overview
- 1–25 years old
- Low-grade glioma with a BRAF V600 gene change
- Newly diagnosed tumor or a tumor that came back or got worse after treatment ended
- Able to safely receive dabrafenib and trametinib