Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
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.
Grade IV Glioma
Grade IV Astrocytoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma|
- Progression Free Survival [ Time Frame: 6-months ] [ Designated as safety issue: No ]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.
- Overall Survival [ Time Frame: 36-months ] [ Designated as safety issue: No ]All patients will be followed until death to measure overall survival.
- Quality of life [ Time Frame: 36-months ] [ Designated as safety issue: No ]Patient quality of life will be assessed throughout the study.
- Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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 to progression [ Time Frame: 36-months ] [ Designated as safety issue: No ]Time-to-progression will be assessed for all patients.
- Objective response rate [ Time Frame: 36-months ] [ Designated as safety issue: No ]Objective response rate will be assessed.
- Cancer immunogenicity [ Time Frame: 36-months ] [ Designated as safety issue: No ]Immunogenic responses to cancer cell vaccination will be measured.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
All patients will receive the full TVI-Brain-1 treatment.
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.
Other Name: Cancer vaccine plus immune adjuvant, plus activated white blood 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.
|United States, Missouri|
|Saint Luke's Hospital|
|Kansas City, Missouri, United States, 64111|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|United States, Wisconsin|
|Aurora BayCare Medical Center|
|Green Bay, Wisconsin, United States, 54311|
|Study Chair:||Gary Wood, Ph.D.||Sponsor GmbH|