Actively Recruiting
Atovaquone Combined With Radiation in Children With Malignant Brain Tumors
Led by Emory University · Updated on 2025-07-22
18
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
M
Morningside Foundation/Peach Bowl LegACy Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of atovaquone combined with standard radiation therapy in children and young adults aged 2 to 25 years who have newly diagnosed pediatric high-grade glioma, diffuse midline glioma, or diffuse intrinsic pontine glioma. The study also aims to assess longer-term use of atovaquone in patients with relapsed or progressed tumors, including medulloblastoma, following radiation therapy. Atovaquone is an approved antiparasitic drug being studied for its potential to improve cancer treatment by inhibiting a protein involved in tumor survival and immune suppression. Participants receive oral atovaquone doses adjusted by age and weight alongside radiation therapy. Newly diagnosed patients begin atovaquone treatment for about two weeks before starting approximately six weeks of combined atovaquone and MRI-guided proton radiation therapy. Those with relapsed or progressive disease or who have completed radiation previously receive atovaquone for up to six months if tolerated, beginning 2 to 4 weeks after relapse, progression, or radiation completion. Throughout the study, participants undergo assessments for drug-related toxicities at baseline and study end, with additional monitoring of tumor progression and survival over one year. Safety evaluations include performance status, liver and organ function tests, and seizure stability. The research team measures progression-free survival, overall survival, and tumor response rates to understand atovaquone’s tolerability and potential impact on these aggressive brain tumors.
CONDITIONS
Brief Title
Atovaquone Combined With Radiation in Children With Malignant Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed pediatric high-grade glioma or diffuse midline glioma patients with confirmed diagnosis or DIPG defined by MRI
- Relapsed or progressive pediatric high-grade glioma, diffuse midline glioma, diffuse intrinsic pontine glioma, or medulloblastoma after radiation therapy
- Age between 2 and 25 years
- Weight greater than 10 kg
- Karnofsky or Lansky performance score above 50%
- Stable seizures without recent medication changes
- Adequate liver, organ, and marrow function as defined by study parameters
- For relapsed patients, recovery from prior treatments and timing since last therapies met
You will not qualify if you...
- Chronic systemic illness or concurrent illness
- Receipt of anti-cancer therapy other than radiation for newly diagnosed patients
- Presence of metastatic tumor in newly diagnosed patients
- Uncontrolled seizures or need for increased anti-epileptic drugs
- Incomplete recovery from prior surgery or acute treatment effects
- History of allergic reactions to atovaquone or similar compounds
- Symptomatic or large intratumoral hemorrhage
- Pregnant or breastfeeding females; reproductive-age participants must use effective contraception during and 3 months after treatment
- Insufficient recovery time from prior therapies including chemotherapy, immunotherapy, radiation, stem cell transplant as specified for relapsed patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks (+/- 7 days)
Participants newly diagnosed with pediatric brain tumors receive Atovaquone alone for 2 weeks to assess tolerance before combined treatment.
Visits as needed for dosing and safety monitoring
Duration - Approximately 6 weeks
Participants receive combined Atovaquone and MRI-guided proton radiation therapy to treat malignant brain tumors.
Daily radiation treatments and regular visits for medication administration and monitoring
Duration - Up to 6 months
Participants with relapsed or progressive tumors receive Atovaquone for up to 6 months in combination with or following radiation therapy, depending on their treatment history.
Regular visits for medication dosing and monitoring
Duration - Up to 12 months
Participants are monitored for drug safety, tumor progression, and survival outcomes after completion of treatment.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 2 locations
1
Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
Children's Healthcare of Atlanta: Scottish Rite
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
T
Tobey MacDonald, MD
A
Amber Kaminski
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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