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.
Who Can Participate?
Eligibility
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
Age Range
12-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1b/2, multicenter study of vorasidenib in combination with temozolomide (TMZ) in participants with IDH1- or IDH2-mutant glioma
Principal Investigator
Katherine
Peters
Protocol Number
PRO00116997
NCT ID
NCT06478212
Phase
I/II
Enrollment Status
Open to Enrollment