Gliomas (Low-Grade) Vaccine Study – Phase II

Protocol Description

The purpose of this research study, initiated at Children’s Hospital of Pittsburgh of UPMC, is to assess the effectiveness of the GAA/TT-peptide vaccine, made from small proteins called peptides and Montanide ISA-51, when used against low-grade gliomas that have grown back despite radiation and/or chemotherapy. The vaccine is intended to use the child’s immune system to attack the abnormal brain tumor cells in much the same way as conventional vaccines prepare the immune system to respond to specific microbes that may attack in the future.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to pediatric patients of both genders, ages 12 months to 21 years, who have low-grade gliomas that have grown back after treatment with radiation and/or chemotherapy.
Males and Females: Ages 12 months to 21 years

Requirements

Following screening for eligibility, participants will receive injections of the vaccine and Poly-ICLC, a drug that helps the immune system respond to the vaccine. These will be given every three weeks for 21 weeks, for an initial total of 8 injections. Barring negative side effects or tumor worsening, the injections may continue at a rate of every 6 weeks for up to 2 years from the first vaccine injection (14 additional injections).
Visits: From 9 to 23, depending on response to therapy
Duration: Up to 2 years

Status: Open to Enrollment

Source(s) of Support

Brain Tumor Translational Research Fund and Connor's Cure Fund, UPMC Children's Hospital of Pittsburgh
National Cancer Institute/National Institutes of Health

Additional Information

Study Description at National Institutes of Health ClinicalTrials.gov
Cancer and Blood Disorder Research

Primary Investigator

Andrew Bukowinski, MD
James Felker, MD
Ian F. Pollack, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinators Melissa Repine or Sharon DiBridge at 412-692-8864.