Vorasidenib in combination with temozolomide (TMZ) in IDH-mutant glioma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug combination of vorasidenib and temozolomide (the study drugs) is a safe and effective option for people who have glioma with IDH1 or IDH2 mutations.

What is the Condition Being Studied?

Astrocytoma or Glioma with IDH1 or IDH2 Mutations

Who Can Participate in the Study?

Children and adults ages 12+ who:

Are diagnoses with a grade 4 glioma, like astrocytoma, with an IDH1 or IDH2 mutation (if you meet the grade 4 designation due to a deletion of CDKN2A/B, you may be able to join)
Have completed standard radiation therapy and temozolomide at the same time at least 6 weeks before joining the study
Have never been treated with vorasidenib or other IDH inhibitors
Are not experiencing any serious side effects of previous anti-cancer treatments

For more information, contact the study team at 919-684-5301.

Grupo etario

Adults, Children

What is Involved?

If you choose to join the study, you will get the study drug regimen in a series of 28-day periods called "drug cycles." The number of cycles you do in the study will depend on how your body tolerates the study drugs and how your cancer respond.

During each cycle, you will:

Take vorasidenib by mouth once per day
Take temozolomide by mouth for the first 5 days of each cycle
Have regular study visits that involve questionnaires, blood tests, electrocardiograms (ECGs), vital sign measurements, and physical exams