Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
The TVI-Brain-1 treatment involves several steps. First, the patient's cancer will be
surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated
with the vaccine formulation. Third, the patient's blood will be filtered for killer T cell
precursors which will then be cultured and stimulated to reach a higher (killer) activity
level. Fourth, the activated cells will be infused into the patient's bloodstream so that
they will be able to attack the cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
To assess the efficacy of TVI-Brain-1 using progression-free survival at 6-months as a surrogate for overall survival. Determining the effect of TVI-Brain-1 on overall survival is the study's most important secondary endpoint.
Gary Wood, Ph.D.
United States: Food and Drug Administration
|Baylor University Medical Center||Dallas, Texas 75246|
|Saint Luke's Hospital||Chesterfield, Missouri 63017|
|Washington University||St. Louis, Missouri 63110|
|Aurora BayCare Medical Center||Green Bay, Wisconsin 54311-6519|