Adoptive Cellular Therapy for Brain Cancer
(ACTION Trial)
Trial Summary
What is the purpose of this trial?
It is believed that the body's immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use a patient's tumor to make a vaccine which we hope will stimulate T-cells to kill tumor cells and leave normal cells alone.High grade gliomas (HGGs) are very aggressive and difficult for the body's immune system to attack. Before T-cells can become active against tumor cells, they require strong stimulation by special "stimulator" cells in the body called Dendritic Cells (DCs) which are also part of the immune system. DCs can recognize the cancer cells and then activate the T lymphocytes, and create this strong stimulation.The purpose of this research study is to learn whether anti-tumor T-cells and anti-tumor DC vaccines can be given safely. Most importantly, this study is also to determine whether the T-cells and DC vaccines can stimulate a person's immune system to fight off the tumor cells in the brain.
Research Team
Elias Sayour, MD, PhD
Principal Investigator
University of Florida
Duane Mitchell, MD, PhD
Principal Investigator
University of Florida
Eligibility Criteria
This trial is for pediatric patients with high-grade gliomas who are scheduled for tumor removal surgery. They must have a certain level of physical function, normal kidney and liver tests, and agree to use birth control. It's not open to those with autoimmune diseases, HIV, severe medical conditions, or pregnant/breastfeeding individuals.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Participants receive dose-intensified temozolomide with TTRNA-DC vaccines and GM-CSF
Immunotherapy
Participants receive TTRNA-xALT vaccine and Td vaccine, with or without autologous hematopoietic stem cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TTRNA-DC vaccines with GM-CSF
- TTRNA-xALT
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Pediatric Cancer Foundation
Collaborator
National Cancer Institute (NCI)
Collaborator
Moffitt Clinical Research Network (MCRN)
Collaborator
National Institutes of Health (NIH)
Collaborator