Researchers Study if Olutasidenib and Temozolomide (TMZ) Can Prolong the Life of Patients With IDH-mutant HGG
Phase: Recruiting
First Posted: March
Condition(s): Diffuse Intrinsic Pontine Glioma (DIPG), High Grade Glioma (HGG)
NCT Number: NCT06161974 Other Study ID Number(s): TarGeT-D
What Is the Purpose of This Study?
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation.
The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
Who Can Take Part in This Study?
People who may be eligible for this study:
- Patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR
- Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resection, without exceptions. The diagnosis of HGG, including DIPG, must have been confirmed through TarGeT-SCR.
- For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, and histopathology consistent with diffuse WHO Grade 2-4 glioma.
- All other HGG must be WHO Grade 3 or 4.
For a full list of eligibility requirements, visit https://www.clinicaltrials.gov/study/NCT06161974
What Will Happen During This Study?
- Mutations in a gene called IDH1 are found in 6% of brain tumors in kids and up to 36% in teens and young adults. These tumors with the IDH1 mutation have special features that make them respond better to treatment and have a better outlook compared to those without the mutation.
- Olutasidenib is a medicine taken by mouth that targets the mutated IDH1 protein in the brain. It has shown to be safe and somewhat effective in adults with these brain tumors.
- Kids and young adults with IDH1-mutant brain tumors will get a combination of olutasidenib and another medicine called temozolomide after radiation therapy. They will take olutasidenib every day for 28 days and temozolomide for the first 5 days of each 28-day cycle. After 13 cycles of both medicines, they will continue with just olutasidenib for another 13 cycles.
- The study will also collect blood, spinal fluid, and possibly more tumor tissue to look for genetic changes and other markers that can help predict how well the treatment is working or if the tumor comes back. They will also check how the patients feel and their quality of life to find ways to predict treatment benefits with less invasive methods.
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Neuro-Oncology
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Diffuse Intrinsic Pontine Glioma (DIPG)
Diffuse intrinsic pontine glioma, also know as DIPG, is an aggressive, malignant brain tumor that develops in a part of the brainstem called the pons.
Brain Tumors
Brain tumors are the most common solid tumors in children. Primary brain tumors start in the brain and usually do not spread outside the brain tissue.