Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas
Stopped early · Phase 1
Conditions studied: Malignant Glioma, High Grade Glioma
In brief
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.
Key facts
- Study ID
- NCT03334305
- Run by
- University of Florida
- People needed
- 18
- Starts
- 2018-08-27
- Expected to finish
- 2025-03-20
- Last updated by the study team
- 2026-04-23
Who can join
Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).
- Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection.
- Subjects with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.
- Severe or unstable concurrent medical conditions.
- Prior allergic reaction to TMZ, GM-CSF, or Td
- Subjects who are unwilling or unable to receive treatment and undergo follow-up evaluations at the enrolled Sunshine Project Consortium treatment site.
Where it is running
- Children's of Alabama at UAB — Birmingham, Alabama, United States
- Children's National Hospital — Washington D.C., District of Columbia, United States
- UF Health Shands Children's Hospital — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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