Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01081223|
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : June 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glioma High Grade Astrocytoma Glioblastoma Multiforme||Biological: Cancer vaccine plus immune adjuvant, plus activated white blood cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Biological: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.
- Relative toxicity [ Time Frame: 8 weeks ]To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.
- Progression free survival [ Time Frame: 6 months ]Evaluate progression free survival at 6 months as a surrogate for overall survival.
- Immunogenicity [ Time Frame: 8 weeks ]The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.
- Overall survival [ Time Frame: 12 months ]Evaluate overall survival of patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081223
|United States, Missouri|
|Saint Luke's Hospital|
|Kansas City, Missouri, United States, 64111|
|Principal Investigator:||Michael Salacz, M.D.||St. Luke's Hospital|