A Vaccine Trial for Low Grade Gliomas
ConditionLow Grade Glioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorJames Felker
About this trial
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.
Eligibility criteria
Qualifiers
Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may have tumor spread within the central nervous system (CNS).
HLA-A2 positive based on flow cytometry.
Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration.
Patients must be ≥ 12 months and < 22 years of age at the time of HLA-A2 screening.
Disqualifiers
Patients living outside of North America are not eligible.
Patients may not have received radiation to the index lesion within 1 year of enrollment.
Interferon (e.g. Intron-A®)
Allergy desensitization injections
Trial design
Treatments tested in this trial
- Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
James Felker
Lead sponsor
University of Pittsburgh
Sponsor institution
Connor's Cure
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov