Atovaquone Combined With Radiation in Children With Malignant Brain Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-25
SponsorEmory University

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

18 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Morningside Foundation/Peach Bowl LegACy Fund

Collaborator