Phase II Study of HLA-A2 Restricted Glioma Antigen Peptide Vaccine with Poly-ICLC in Children and Young Adults With Recurrent Unresectable Low-Grade Gliomas

What this Trial Is About

This research aims to evaluate the immune response, safety, and early signs of effectiveness of a vaccine combining glioma-associated antigen GAAtetanus toxoid TT peptides with poly-ICLC in children and young adults aged 12 months to under 22 years who have unresectable low-grade gliomas. Participants must have previously undergone at least two chemotherapy or biological treatments, including radiation therapy if applied more than one year prior to enrollment. The study focuses on those who are HLA-A2 positive and clinically stable. Participants will receive subcutaneous injections of the GAATT vaccine starting at Week 0, repeated every three weeks for up to eight doses or until treatment must be stopped. Following each vaccine dose, an intramuscular injection of poly-ICLC will be administered near the vaccine injection site. Doses may be given within one week of the scheduled date to accommodate scheduling flexibility. The intervention group includes all participants receiving these combined treatments. Throughout the study, participants will have clinical visits and MRI scans to monitor tumor response and any adverse effects. MRIs will be performed at Weeks 6, 15, and 24 to assess tumor shrinkage or stability. Participants will be observed for possible side effects, including regimen limiting toxicity, and asked to report any temperature changes after treatment. The primary outcome measure is tumor shrinkage or stable disease at Week 24, with safety and immunogenicity also assessed during follow-up.

A Vaccine Trial for Low Grade Gliomas