Emory University
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.
Atovaquone, an FDA-approved antiparasitic drug, is being explored as a potential treatment for certain cancers, particularly leukemia and pediatric brain tumors like high-grade gliomas. Since Atovaquone's safety and dosage are already established, repurposing it for cancer treatment is cost-effective. Research shows that Atovaquone can inhibit a protein called STAT3, which is involved in cancer cell survival and immune response suppression. By doing this, it may enhance the effectiveness of radiation therapy, especially in tumors with low oxygen levels. In animal studies and early clinical tr…
Inclusion Criteria: -Stratum 1 * 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. * Adequate li…
Atovaquone oral suspension (750 mg/5mL) will be administered with meals on an outpatient basis. Patients 13 years and older will receive atovaquone 750 mg PO BID, the standard pediatric dosing for Pneumocystis Jirovecii Pneumonia (PJP) prevention and treatment. For those aged 2-12 years, atovaquone will be dosed at 30mg/kg once daily. The maximum dose for children under 12 will be 1500 mg.
54-60 Gy in 1.8 Gy daily fractions of MRI-guided proton radiotherapy using intensity-modulated pencil-beam scanning technology to match the target will be used.
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