Recruiting

New medication combined with chemotherapy after radiation for brain tumors

Plain-English translation of NCT06161974 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new medication called olutasidenib combined with temozolomide (a chemotherapy drug) as a maintenance treatment for young people ages 12–39 who have been newly diagnosed with aggressive brain tumors that contain an IDH1 genetic mutation. After you complete radiation therapy, you would take the medication to help prevent the tumor from coming back. Researchers want to see if this combination can help patients live longer without their cancer growing.

Aggressive brain tumors in young people are very serious and hard to treat with current therapies alone. This medication targets a specific genetic change found in some of these tumors, which means it may work better for patients who have this mutation.

Do you qualify?

You likely qualify if…

you are between 12 and 39 years old at the time of enrollment
you have been newly diagnosed with an aggressive brain tumor (including certain types like diffuse intrinsic pontine glioma) that has an IDH1 genetic mutation
you have had tumor tissue removed or biopsied for genetic testing that confirms your specific IDH1 mutation type
you have completed radiation therapy before starting this trial medication
you weigh at least 35 kilograms (77 pounds)
you have a performance level (ability to do daily activities) of 50% or better

You likely don't qualify if…

you have cancer that has spread to other parts of your body outside the brain
you have received other cancer medicines for your brain tumor (except for chemotherapy given during radiation and bevacizumab with proper washout time)
you have an IDH2 genetic mutation instead of IDH1
you have a specific type of tumor called oligodendroglioma with certain genetic changes

What participation looks like

You would take the new medication by mouth combined with chemotherapy pills for about 6 months (13 cycles), followed by 6 more months of just the new medication alone. Throughout the trial, you'll have regular clinic visits for blood tests, scans to check your tumor, and physical exams to monitor how you're doing and watch for any side effects. The trial will follow your progress to see if this combination helps keep your tumor from growing.

AI-generated summary from trial data · Jun 17, 2026 · Not medical advice

Trial locations(20 sites)

United States

Children's Hospital Colorado, Aurora, Colorado

Children's National Medical Center, Washington D.C., District of Columbia

University of Miami Hospital and Clinics, Miami, Florida

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois

Susan Chi, Boston, Massachusetts