RecruitingPhase 1NCT06624371

Atovaquone Combined With Radiation in Children With Malignant Brain Tumors


Sponsor

Emory University

Enrollment

18 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 2 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests atovaquone — a medicine normally used to treat parasitic infections — combined with standard radiation therapy in children with aggressive brain tumors (high-grade gliomas, including DIPG). Laboratory research suggests atovaquone may make tumors more vulnerable to radiation, and this trial will see if that holds true in children. **You may be eligible if...** - Your child has a newly diagnosed aggressive brain tumor (pediatric high-grade glioma, diffuse midline glioma, or DIPG) confirmed by imaging or biopsy - Your child weighs more than 10 kg - Your child has reasonable physical function (Karnofsky/Lansky score above 50%) - Seizures, if present, are stable for at least 7 days - Your child has adequate liver and kidney function **You may NOT be eligible if...** - Your child has already received cancer treatment for this tumor - Your child has severe liver or kidney problems - Your child has known allergies to atovaquone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtovaquone

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.

RADIATIONRadiation Therapy

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.


Locations(2)

Arthur M Blank Hospital

Atlanta, Georgia, United States

Children's Healthcare of Atlanta: Scottish Rite

Atlanta, Georgia, United States

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NCT06624371


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