This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.
This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The general procedures include the collection and testing of cancer tissue samples after surgery and chemoradiation therapy (radiation and temozolomide). For the patients randomized into the investigational study treatment group, they will also receive two vaccinations created from their own cancer cells, undergo leukapheresis to collect immune T-cells from their blood, and transfer of those activated effector T-cells after chemoradiation therapy. All patients are followed with MRIs at follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Attenuated autologous cancer cells and activated autologous blood-derived t cells
Surgery for tumor removal or debulking to minimize tumor burden
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.
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 .
Center for Neurosciences
Tucson, Arizona, United States
Cedar-Sanai Medical Center
Los Angeles, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Aaron Mammoser
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Capital Health
Pennington, New Jersey, United States
Providence St. Vincent
Portland, Oregon, United States
Survival
All Subjects will be evaluated and contacted to evaluate their status
Time frame: From date of randomization until the date of death from any cause assessed up to 24 months after randomization.
Progression-free survival
Time to progression is evaluated by review and analysis of serial MRI's taken at specific Time to progression is evaluated by review and analysis of serial MRI's taken at specific timepoints
Time frame: From date of randomization until the date of first documented progression assessed up to 24 months after randomization
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