A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors
Washington University School of Medicine
Summary
The purpose of this research study is to learn about the safety and feasibility of giving a personalized DNA vaccine to people with central nervous system tumors that have returned or have been resistant to treatment.
Eligibility
- Age range
- Up to 25 years
- Sex
- All
- Healthy volunteers
- No
Step 1 Eligibility Criteria for Tissue Sequencing Inclusion Criteria: * Any patient between the ages of 12 and 25 years of age (inclusive) who was diagnosed with any of the following: * High-grade glioma (HGG); newly diagnosed patients * Diffuse midline glioma (DMG); newly diagnosed patients * A pediatric CNS (brain or spine) tumor of any histologic subtype, who has now developed recurrent or refractory disease. * All patients enrolled in this trial will receive treatment for pediatric CNS tumors, including systemic agents, investigational agents, or radiation therapy, prior to receiv…
Interventions
- BiologicalPersonalized neoantigen DNA vaccine
At each vaccination time point, patients will receive one injection of the neoantigen DNA vaccine, one injection into the vastus lateralis.
- DevicePapivax Biotech TDS-IM v2.0
All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM v2.0 device - Papivax Biotech).
- ProcedurePeripheral blood draw
-After trial enrollment and up to 7 days after the first vaccine dose (baseline); no more than 2 weeks after the 3rd vaccine dose; no more than 2 weeks after the 6th vaccine dose; two weeks after the last dose; time of progression or discontinuation (optional)
Location
- Washington University School of MedicineSt Louis, Missouri