About this trial
The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma/diffuse midline glioma/diffuse intrinsic pontine glioma (pHGG/DMG/DIPG).
The secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of RT and before progression.
Eligibility criteria
Qualifiers
Newly diagnosed pHGG/DMG/DIPG Patients must have histologically confirmed pediatric high-grade glioma (pHGG, WHO Grade 3 or 4) or diffuse midline glioma with altered H3K27 (DMG, WHO Grade 4). Primary pHGG or DMG spinal tumors are eligible. Diffuse intrinsic pontine glioma (DIPG) defined by MRI does not require histological confirmation.
Weight > 10kg
Karnofsky and Lansky performance score > 50%
Patients with stable seizures (e.g., no seizures for ≥ 7 days and not requiring escalation or addition of anti-epileptic drugs) will be eligible.
Disqualifiers
Chronic systemic concurrent illness
Concurrent or history of anti-cancer therapy other than RT
Patients with metastatic tumor are excluded for Stratum 1 only.
Patients with uncontrolled seizures or seizure requiring escalation or addition of anti-epileptic drugs are excluded.
Trial design
Treatments tested in this trial
- Atovaquone
- Radiation Therapy
Treatment groups
Sponsors and collaborators
Emory University
Lead sponsor
Morningside Foundation/Peach Bowl LegACy Fund
Collaborator