TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Saint Luke's Hospital
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Baylor University Medical Center
Dallas, Texas, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Progression of Disease
To assess the efficacy of TVI-Brain-1 on patients to evaluate progression free survival. MRI data is used to evaluate tumor progression; success is defined if a patient is still alive and has \< 25 % increase in Tumor volume in MRI collected at 6 month timepoint.
Time frame: 6-months
Overall Survival
All patients will be followed until death or the end of the study to measure overall survival.
Time frame: 32 months
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Toxicity will be assessed throughout the study by recording clinical symptoms, performing physical examinations, measuring vital signs and performing clinical laboratory tests, including complete blood counts and differentials, blood chemistries and autoimmune profiles.
Time frame: 12 weeks
Time to Progression of Tumor Per MRI
Time to progression is defined date of evidence of increase in tumor volume as evaluated by review and analysis of imaging, using MacDonald Criteria in review of serial MRI's taken at specific timepoints
Time frame: 32-months
Objective Response Rate
Time to progression is defined as assessed by neurologists and radiologists evaluation of time to worsening of patient's neurological status and/or increase in tumor volume measurements as evaluated by review and analysis of serial physical exams and MRI's taken at specific timepoints
Time frame: 32-months
Delayed-type Hypersensitivity (DTH) Skin Testing
Skin Test using attenuated autologous cancer cells will be performed to assess the immunogenicity of the Subject's cancer. Evidence of a Resulting wheal or flare reaction from sub-cutanous injection of test will be evaluated in each patient
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Time frame: 48 hours
Quality of Life as Measured by FACT-Br Tool Score
Quality of life data using the FACT-Br score tabulation from responses on validated tool
Time frame: 32 months