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
131 weeks
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
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.
CONDITIONS
Official 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 (WHO Grade 3 or 4), diffuse midline glioma with altered H3K27 (WHO Grade 4), or diffuse intrinsic pontine glioma defined by MRI (Stratum 1)
- Weight greater than 10 kg
- Karnofsky or Lansky performance score above 50%
- Stable seizures with no seizures for at least 7 days and no need to increase anti-epileptic drugs
- Adequate liver function: total bilirubin ≤ 2x upper limit of normal, AST and ALT ≤ 225 U/L (5x ULN)
- Normal organ and marrow function including neutrophil count > 1,000/mcL, platelets > 100,000/mcL, hemoglobin > 8 g/dL, creatinine within normal limits or clearance > 60 mL/min/1.73m2
- For relapsed or progressive patients (Stratum 2): pHGG/DMG/DIPG or medulloblastoma after radiation without prior atovaquone, any metastatic disease allowed
- Previous standard treatment including surgery, radiation, and/or chemotherapy completed with recovery from acute toxicities
- Age between 2 and 25 years
- Weight greater than 10 kg
- Karnofsky or Lansky performance score above 50%
- Stable seizures as above
- Normal organ and marrow function as above
- Adequate liver function as above
You will not qualify if you...
- Chronic systemic concurrent illness (Stratum 1)
- Concurrent or prior anti-cancer therapy other than radiation (Stratum 1)
- Metastatic tumor (Stratum 1)
- Uncontrolled seizures or seizures requiring escalation of anti-epileptic drugs
- Not fully recovered from acute effects of prior surgery
- History of allergic reactions to atovaquone or similar compounds
- Symptomatic or large intratumoral hemorrhage prior to enrollment
- Pregnant or breastfeeding women
- For males or females of reproductive potential, not agreeing to effective contraception during and 3 months after treatment
- For relapsed patients (Stratum 2): concurrent illness
- Not recovered from prior therapies as specified (myelosuppressive therapy, biologic agents, antibodies, immunotherapy, radiation, stem cell transplant) within defined timeframes
- Patients with uncontrolled seizures or requiring increased anti-epileptic drugs
- Not fully recovered from acute effects of prior surgical intervention
- Allergic to atovaquone or related compounds
- Pregnant or breastfeeding women and those not agreeing to contraception as above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Amber Kaminski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here