Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
|ClinicalTrials.gov Identifier: NCT01290692|
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Grade IV Glioma Grade IV Astrocytoma Glioblastoma Multiforme||Biological: TVI-Brain-1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||February 2014|
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
- Progression Free Survival [ Time Frame: 6-months ]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 ]All patients will be followed until death to measure overall survival.
- Quality of life [ Time Frame: 36-months ]Patient quality of life will be assessed throughout the study.
- Toxicity [ Time Frame: 12 weeks ]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 ]Time-to-progression will be assessed for all patients.
- Objective response rate [ Time Frame: 36-months ]Objective response rate will be assessed.
- Cancer immunogenicity [ Time Frame: 36-months ]Immunogenic responses to cancer cell vaccination will be measured.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290692
|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|