Research

Immunotherapy for Childhood Gliomas

Treatment of Newly Diagnosed Brainstem Gliomas and Non-Brainstem High-Grade Gliomas, Recurrent Low-Grade and High-Grade Gliomas

Protocol Description

The purpose of this study is to see if vaccination with a “cocktail” of glioma epitope peptide, combined with the immunoadjuvant polyICLC, can induce immune responses in children with newly diagnosed or recurrent gliomas. Eligible patients are stratified by tumor and prior treatment:

Newly diagnosed pontine or malignant brainstem gliomas in patients who have received radiation therapy alone
Newly diagnosed non-brainstem malignant gliomas in patients who have received radiation therapy alone
Newly diagnosed high-grade gliomas, pontine gliomas, and malignant brainstem gliomas in patients who received chemotherapy during radiation therapy. Patients may not have received chemotherapy after completing radiation therapy.
Recurrent non-brainstem high-grade gliomas
Progressive recurrent low-grade gliomas

Eligibility Criteria

Subject to certain exclusion criteria, the trial is enrolling participants of both genders, ages 18 months to 21 years, who satisfy study criteria, including having either a newly diagnosed, incompletely resected, non-brain stem high-grade glioma; a newly diagnosed diffuse intrinsic pontine glioma or any biopsy-proven high-grade glioma; or a recurrent low- or high-grade glioma. Patients must have the HLA-A2 tissue type.
Males: Ages 18 months to 21 years
Females: Ages 18 months to 21 years

Requirements
A vaccine made from small proteins specific to gliomas wil be given in combination with an experimental drug called Poly-ICLC, which boosts the immune system. Both will be given by subcutaneous injections at 3-week intervals for the first 24 weeks. Responding patients may continue receiving vaccines every 6 weeks for up to 2 years. Physical examinations, blood testing, and MRI scans will be performed periodically.
Frequency of visits: Every 3 weeks for 8 times, then every 6 weeks up to 2 years
Duration: Up to 2 years for treatment

Status: Open For Enrollment

Sources of Support
The Brain Tumor Society
Musella Foundation
National Institutes of Health

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Regina I. Jakacki, MD

Ian F. Pollack, MD

Hideho Okada, MD, PhD