Study Information
Summary / Purpose
This phase III trial compares the effect of vorasidenib to placebo in combination with usual treatment, temozolomide, in treating patients with newly diagnosed grade 3 astrocytoma after radiation.
Study Type: Interventional
Accepts Healthy Volunteers: No
Who Can Participate
Eligibility Criteria: - Adults 18+ years of age
- Confirmed diagnosis of astrocytoma, IDH-mutant (CNS WHO grade 3)
- Presence of IDH1 p.R132 or IDH2 p.172 mutation
- Absence of CDKN2A/B homozygous deletion
- Absence of whole arm 1p/19q co-deletion
- No evidence of spinal or leptomeningeal disease
- No prior chemotherapy, cranial irradiation, IDH-inhibitor therapy, radiotherapy, vaccine therapy, small-molecule therapy, or laser ablation
What's Involved
Participation in the study will include: - Random assignment to receive temozolomide with either vorasidenib or a placebo, taken by mouth
- Radiation therapy to the brain, which may be given as intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or proton therapy
- Magnetic resonance imaging (MRI) of the brain before treatment begins and throughout the study to check how the tumor responds
- Blood samples to monitor your health and watch for side effects
- Completing questionnaires about your symptoms and quality of life
- Attending scheduled treatment and follow-up visits
Principal Investigator
Additional Information
Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.
