A Phase 2 Study of Vorasidenib and Temozolomide in People With Grade 4 Glioma

Full Title

Purpose

Researchers are seeking the best doses of vorasidenib and temozolomide to treat glioma and assessing how well they work together. The people in this study have grade 4 gliomas with a mutation (change) in the IDH1 or IDH2 gene. These mutations can cause cancer cells to multiply and spread.

Vorasidenib blocks mutated IDH proteins that contribute to cancer growth and survival. Temozolomide is a standard medical treatment for glioma. Together these drugs may slow or stop cancer growth. They are both taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

• Have grade 4 glioma, such as 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 received standard radiation therapy and temozolomide at the same time before joining the study. This treatment must have been completed no more than 6 weeks before starting the study therapy.
• Have not previously received vorasidenib or other IDH inhibitors.
• Have recovered from the serious side effects of prior anti-cancer treatments before getting the study therapy.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 12 or older.

Contact

For more information or to see if you can join this study, please call Dr. Ingo Mellinghoff’s office at 646-888-2766.