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Hippocampal-Avoidance Proton Therapy for Low-Grade Glioma

This study is looking at a special type of radiation therapy called hippocampal-avoidance proton therapy for children and young adults aged 6 to 21 with certain low-grade gliomas (brain tumors). The goal is to see if this treatment can reduce the radiation dose to the hippocampus (the part of the brain important for memory) while still treating the tumor effectively. This is important because many patients with these tumors live for a long time after treatment, and memory problems can be a side effect of traditional radiation. The study will measure if the treatment plans successfully meet specific dose limits to the hippocampus. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 74 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive weekly MRI scans during proton therapy. Neurocognitive (brain function) tests will be done at the start and continue for up to 5 years after treatment.
Compensation
Not stated in the trial record.
Follow-up
Neurocognitive outcomes will be collected for up to 5 years after therapy. Disease evaluation will be monitored with brain MRI.

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NCT04065776

Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma

Recruiting
NAAges 6–21InterventionalTreatment
St. Jude Children's Research Hospital
~74 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Hippocampal-avoidance proton therapy

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of plans meet the first or second dose constraints.
Measured over 4 years after activation

Conditions

Glioma
Pilocytic Astrocytoma
Pilomyxoid Astrocytoma
Pleomorphic Xanthoastrocytoma
Ganglioglioma
Optic Pathway Glioma
Diffuse Astrocytoma

Explore related trials

Diffuse AstrocytomaGangliogliomaLow Grade GliomaPilocytic AstrocytomaPilomyxoid AstrocytomaPleomorphic XanthoastrocytomaVisual Pathway Glioma

Where it's being run

2 sites across 2 states
Minnesota1
Tennessee1

Study leadership

  • Thomas Merchant, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Thomas Merchant, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must have a diagnosis of pilocytic astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, optic pathway glioma, diffuse astrocytoma, low-grade neuroepithelial tumor, low-grade glioneuronal tumor or LGG, or not otherwise specified (NOS).
Patient with eligible diagnosis other than optic pathway glioma or tumors of the brainstem/midbrain/tectum has histologic verification of disease at diagnosis or recurrence OR
Patient with optic pathway glioma or tumors of the brainstem/midbrain/tectum has radiologic verification of disease at diagnosis or recurrence
A repeat biopsy was done because the recurrent tumor was enhancing but did not originally enhance because there was a high index of suspicion regarding high-grade transformation
Tumor must be located in the suprasellar region or midline structures. Midline structures include, but are not limited to, the thalamus, basal ganglia, internal capsule, midbrain, tectum, third ventricle, fourth ventricle, cerebellum, pons, and medulla. Tumors may involve the optic pathway. For questions about tumor locations that are not specified on this list, please contact the Study PI.
Patients must be at least 6 years but less than 22 years of age at the time of enrollment.
Patients must have a performance status greater or equal to 70 (use Karnofsky scale for patients aged 16 years and older and Lansky scale for patients aged less than 16 years).
Patients may not receive concurrent chemotherapy or targeted therapy, including but not limited to BRAF-inhibitors and MEK-inhibitors.
All patients must be able to undergo contrast-enhanced brain MRI.
All patients must have adequate organ function as described below.
Peripheral absolute neutrophil count (ANC) ≥ 1000/µL
Platelet count ≥ 10,000/µL (transfusion independent)
Patients with seizures may be enrolled if well controlled on anticonvulsants

Exclusion

Patients may not have received prior CNS radiation.
Patients with gross total resection and no measurable disease via MRI are not eligible. Patients must have measurable disease of at least 1 cm via MRI.
Patients with evidence of metastatic disease are not eligible.
Patients with WHO grade II midline tumors that harbor the H3K27M mutation, IDH-mutant gliomas, grade II ependymomas and subependymomas, pituicytomas, spindle cell oncocytomas, or granular cell tumors of the sellar region are not eligible.
Patients with tumors that directly invade the hippocampus or with gross tumor volumes that extend into the hippocampus are not eligible.
Patients with tumors in the spine or cervicomedullary junction.
Females of child-bearing potential cannot be pregnant or breast feeding. Female participants \> 10 years of age or post menarche must have a negative serum or urine pregnancy test before enrollment. Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Patients who are status post resection of bilateral hippocampi. Patients who are status post resection of one hippocampus will be eligible for the study and the hippocampal dose constraints will be applied to the intact hippocampus.

What this trial measures

  • Percentage of plans meet the first or second dose constraints.4 years after activation

    To determine the feasibility of HA with proton therapy in suprasellar or midline LGGs. Feasibility will be established if 70% of plans meet the first or second dose constraints. First RT dose constraints for bilateral hippocampi: volume receiving 40 CGE (V40CGE) ≤ 25%, dose to 100% of hippocampus (D100%) ≤ 5CGE. Second RT dose constraints for bilateral hippocampi: V40CGE ≤ 35%, D100% ≤ 10 CGE.