120
Participants
Start Date
September 15, 2023
Primary Completion Date
December 31, 2026
Study Completion Date
March 31, 2027
TVI-Brain-1
Attenuated autologous cancer cells and activated autologous blood-derived t cells
Standard of Care
Surgery for tumor removal or debulking to minimize tumor burden
Radiotherapy
Conformal radiotherapy consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks.
Temozolomide
All Subjects receive 75 mg/m2 of temozolomide daily beginning on the first day of radiotherapy and continuing until the completion of radiotherapy. Standard of care Subjects will also receive adjuvant temozolomide .
Aaron Mammoser, Atlanta
Moffitt Cancer Center, Tampa
University of Kansas Medical Center, Kansas City
Center for Neurosciences, Tucson
Cedar-Sanai Medical Center, Los Angeles
University of Southern California Keck School of Medicine, Los Angeles
Providence St. Vincent, Portland
Capital Health, Pennington
Lead Sponsor
TVAX Biomedical
INDUSTRY