About this study
Astrocytoma and oligodendroglioma are types of low-grade gliomas. Some of these brain tumors have a change in a gene called IDH1 or IDH2. The drug vorasidenib blocks abnormal proteins made by these gene changes. This type of treatment is called targeted therapy. Vorasidenib has been studied mostly in adults. More research is needed to learn how the drug affects teens, including their growth and development.
This study is for people ages 12–17 who have astrocytoma or oligodendroglioma. The tumor must have an IDH1 or IDH2 gene change. They must have had surgery or a biopsy but no other cancer treatment.
Everyone in the study will take vorasidenib by mouth one time each day. The dose will be based on the person’s weight. Treatment will continue unless the tumor gets worse, side effects become too serious, or the person needs another cancer treatment. People may also choose to stop treatment at any time.
During the study, participants will have:
- Clinic visits
- Physical exams
- Blood tests
- Heart tests
- MRI scans
The study team will check the tumor and watch for side effects. They will also check height, weight, bone age, and signs of growth and development. Vorasidenib may affect the liver, so the study team will check liver health with blood tests.
We need to learn whether vorasidenib is safe for teens with these brain tumors. We also need to learn how the body handles the drug, whether it helps control the tumor, and whether it affects growth and development.
Eligibility overview
- Age 12–17 years
- Has grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 gene change
- Has had surgery or a biopsy but no chemotherapy, radiation therapy, or other cancer treatment
- Does not need chemotherapy or radiation therapy right away
- Has a tumor that can be measured on an MRI