Immunotherapy + Radiotherapy for Brain Stem Glioma
(BRAVO Trial)
Trial Summary
What is the purpose of this trial?
The standard of care for children with DIPG includes focal radiotherapy (RT) but outcomes have remained dismal despite this treatment. The addition of oral Temozolomide (TMZ) concurrently with RT followed by monthly TMZ was also found to be safe but ineffective. Recent studies in adults have shown that certain types of chemotherapy induce a profound but transient lymphopenia (low blood lymphocytes) and vaccinating and/or the adoptive transfer of tumor-specific lymphocytes into the cancer patient during this lymphopenic state leads to dramatic T cell expansion and potent immunologic and clinical responses. Therefore, patients in this study will either receive concurrent TMZ during RT and immunotherapy during and after maintenance cycles of dose-intensive TMZ (Group A) or focal radiotherapy alone and immunotherapy without maintenance DI TMZ (Group B). Immune responses during cycles of DC vaccination with or without DI TMZ will be evaluated in both treatment groups.
Research Team
Elias Sayour, MD, PhD
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for children with a specific brain tumor called DIPG or other diffuse intrinsic brain stem gliomas. They must be stable after surgery, have certain blood and organ function levels, and agree to use birth control if applicable. Those with severe allergies to the drugs used in this study, significant organ dysfunction, unstable medical conditions, or who cannot follow the study procedures are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive focal radiotherapy, with Group A receiving concurrent Temozolomide
Immunotherapy
Participants receive TTRNA-DC vaccines and adoptive cellular therapy, with Group A receiving dose-intensified Temozolomide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide + Fludarabine Lymphodepletive Conditioning
- Dose-Intensified TMZ
- TTRNA-DC vaccines with GM-CSF
- TTRNA-xALT
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Lyla Nsouli Foundation
Collaborator
Accelerate Brain Cancer Cure
Collaborator