Using proton therapy to avoid the hippocampus in treating low-grade gliomas
A Phase II Study of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
This study is testing whether using proton therapy while protecting the memory areas of the brain can safely treat patients with low-grade brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT04065776 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using proton therapy with hippocampal avoidance for patients with low-grade gliomas located in the midline or suprasellar regions. Patients will receive targeted radiation therapy while minimizing exposure to the hippocampi, which is crucial for memory function. Weekly MRI scans will monitor tumor changes during treatment, and neurocognitive outcomes related to memory and learning will be assessed over five years post-therapy. The primary goal is to determine if 70% of treatment plans can adhere to specified dose constraints for the hippocampi.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with specific types of low-grade gliomas located in the suprasellar region or midline structures.
Not a fit: Patients with high-grade gliomas or those whose tumors are not located in the specified regions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce memory deficits in children treated for low-grade gliomas.
How similar studies have performed: Other studies have shown promise in using proton therapy for brain tumors, but this specific approach of hippocampal avoidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (Completed)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Merchant, MD — St. Jude Children's Research Hospital
- Study coordinator: Thomas Merchant, MD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.