Actively Recruiting
A Phase II Study of Hippocampal-Avoidance Proton Therapy for Children and Young Adults With Low-Grade Glioma
Led by St. Jude Children's Research Hospital · Updated on 2026-04-24
74
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Low-grade gliomas (LGGs) are the most common brain tumors in children, with some treated using focal radiation therapy (RT). Survivors often experience memory problems, especially in verbal recall, which affects daily functioning and quality of life. This study evaluates using proton therapy to reduce radiation doses to the hippocampi, brain areas linked to memory, in children and young adults with midline or suprasellar LGGs to see if this approach is feasible and less harmful to memory. Participants will receive hippocampal-avoidance proton therapy, delivering 52.2 or 54 cobalt gray equivalents (CGE) over 29 or 30 treatment sessions depending on tumor location. Weekly MRI scans during treatment will monitor tumor changes and may lead to therapy adjustments to protect healthy tissue. Neurocognitive tests focused on memory and learning will be done before treatment and up to five years after to assess effects. During the study, patients will have regular brain MRI scans and memory assessments including the California Verbal Learning Test and Cogstate tests at baseline, three years, and five years. Researchers will track treatment plan success rates, event-free survival at three years, cognitive changes, and tumor progression. Additional tests include advanced brain scans and blood samples to study tumor biology. Safety monitoring will include checking for hormone, vision, hearing, and blood vessel problems over time.
CONDITIONS
Brief Title
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of pilocytic astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, optic pathway glioma, diffuse astrocytoma, low-grade neuroepithelial tumor, low-grade glioneuronal tumor, or low-grade glioma (LGG) not otherwise specified
- Histologic confirmation of disease at diagnosis or recurrence for eligible tumors other than optic pathway glioma or brainstem/midbrain/tectum tumors; radiologic confirmation allowed for optic pathway glioma or brainstem/midbrain/tectum tumors
- Tumor located in the suprasellar region or midline structures such as thalamus, basal ganglia, internal capsule, midbrain, tectum, third or fourth ventricle, cerebellum, pons, or medulla; tumors may involve the optic pathway
- Age 6 years or older but less than 22 years at enrollment
- Performance status of 70 or higher (Karnofsky scale for 16 years and older, Lansky scale for under 16 years)
- No concurrent chemotherapy or targeted therapy including BRAF or MEK inhibitors
- Able to undergo contrast-enhanced brain MRI
- Adequate organ function including neutrophil count ≥ 1000/µL, platelet count ≥ 10,000/µL, and well-controlled seizures if present
You will not qualify if you...
- Prior central nervous system radiation treatment
- Gross total tumor resection with no measurable disease on MRI; must have measurable disease of at least 1 cm
- Evidence of metastatic disease
- Presence of certain tumor types including WHO grade II midline tumors with H3K27M mutation, IDH-mutant gliomas, grade II ependymomas, subependymomas, pituicytomas, spindle cell oncocytomas, or granular cell tumors of the sellar region
- Tumors directly invading or extending into the hippocampus
- Tumors located in the spine or cervicomedullary junction
- Female participants of child-bearing potential who are pregnant or breastfeeding; females over 10 years or post-menarche must have negative pregnancy test; both males and females of reproductive potential must agree to effective contraception
- Patients with bilateral hippocampi resection; resection of one hippocampus allowed with dose constraints applied to intact hippocampus
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 - Approximately 6 weeks
Participants receive hippocampal-avoidance proton therapy in 29 or 30 fractions depending on tumor location. Weekly MRI scans are performed during treatment to monitor tumor changes and guide adaptive therapy if needed.
Weekly visits for proton therapy and MRI scans
Duration - Up to 5 years post treatment
Participants undergo neurocognitive assessments and brain MRI scans to monitor disease and cognitive outcomes for up to 5 years post therapy.
Periodic visits for neurocognitive testing and brain MRI
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
T
Thomas Merchant, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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