Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed
to provide cells for the vaccine. Second, the patient will be vaccinated twice with those
cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will
then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the
activated white blood cells will be infused into the patient's bloodstream so that they will
be able to attack the cancer. Finally, the entire process starting with vaccination will be
repeated, for a total of two rounds of therapy.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.
Michael Salacz, M.D.
St Luke's Hospital
United States: Food and Drug Administration
|Saint Luke's Hospital||Chesterfield, Missouri 63017|