Gliomas Vaccine Study – Pilot

Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides With Poly-ICLC for Children With Gliomas

Protocol Description

The purpose of this study is to see if vaccination with a “cocktail” of glioma epitope peptide, combined with the immunoadjuvant Poly-ICLC, can induce immune responses in children with newly diagnosed or recurrent gliomas. Eligible patients are stratified by tumor and prior treatment, and the study continues to enroll patients with newly diagnosed non-brainstem malignant gliomas who have received radiation therapy alone.

Eligibility Criteria

Subject to certain exclusion criteria, the trial is enrolling participants of both genders, ages 18 months to 21 years, newly diagnosed with non-brainstem, high-grade malignant gliomas who have received prior radiation therapy. 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 will be given in combination with an experimental drug called Poly-ICLC, which boosts the immune system. The vaccine will be given by subcutaneous injection, and the Poly-ICLC will be given by intramuscular injection in close proximity to the vaccine injection site. Both will be given 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

Source(s) of Support

The Brain Tumor Society
Musella Foundation
National Institutes of Health

Primary Investigator

Scott Maurer, MD
Ian F. Pollack, MD

Contact Information

For more information about the study or enrollment, please contact:

Research Coordinators

Carole Rimer, RN, MBA

Mary Petrany, RN

412-692-8864