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RECRUITING
NCT02358187
PHASE2

A Vaccine Trial for Low Grade Gliomas

Sponsor: James Felker

View on ClinicalTrials.gov

Summary

The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)/tetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.

Official title: A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas (LGG)

Key Details

Gender

All

Age Range

12 Months - 21 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2015-01

Completion Date

2028-12-31

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC

Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg/kg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients/parents will be asked to report any temperature elevations and side effects after each treatment.

Locations (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States