Atovaquone Combined With Radiation in Children With Malignant Brain Tumors

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06624371
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • High-grade Glioma
  • Medulloblastoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Atovaquone — DRUG
    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.
  • Radiation Therapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Mar 28, 2025
Status verified
Jul 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1:
    Newly diagnosed pHGG/DMG/DIPG patients. New Diagnosis followed by 2 weeks (+/- 7 days) atovaquone followed by approx. 6 weeks Atovaquone + Radiotherapy
  • Experimental: Stratum 2
    Stratum 2 will be bifurcated into: * Stratum 2a (patients with relapse or progression) * Stratum 2b (patients without progression after radiation) The same dosing regimen for atovaquone will be used for up to 6 months in the absence of toxicity, intolerance, or tumor progression. Patients will begin therapy between 2-4 weeks after documented relapse or progression of tumor or between 2-4 weeks after completion of standard RT for pHGG/DMG/DIPG patients who have completed standard Radiotherapy without previous atovaquone treatment.

Primary Outcome Measure

Drug Limiting toxicities (DLT) in Stratum 1 [ Time Frame: Baseline, end of study (10 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Arthur M Blank HospitalAtlantaGeorgia30329
Tobey MacDonald, MD
Amber Kaminski
[email protected]
Children's Healthcare of Atlanta: Scottish RiteAtlantaGeorgia30342
Tobey J MacDonald, MD
[email protected]
404-727-1447
Amber Kaminski
[email protected]
Tobey MacDonald, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Arthur M Blank Hospital· Atlanta, GAChildren's Healthcare of Atlanta: Scottish Rite· Atlanta, GA

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