Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
Brain Stem Glioma
Biological: autologous dendritic cells
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma|
- Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||April 2012|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Patients will have their white blood cells removed and grown in culture under conditions to make dendritic cells. Dendritic cells are a small group of cells that belong to the white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system. In previous clinical trials, brain tumor cells called astrocytoma tumor cells and glioblastoma tumor cells were taken from the tumor that was removed during surgery. The brain tumor cells were then placed into a solution in the laboratory that made them grow. Certain parts of the brain tumor's proteins (peptides) were removed from the growing tumor cells and mixed together with the dendritic cells in the blood taken from a vein. This combination of dendritic cells and brain tumor peptides were injected into the patient's skin, like a vaccination. This process is similar to that used in vaccinations. The patients were given three and four injections of dendritic cells mixed with the tumor peptides over the course of a twenty-eight day period.
In this study, the proteins that are manufactured and known to be associated with brain cancers will be mixed with the dendritic cells obtained during leukopheresis (a procedure in which the dendritic cells are separated from the patients' blood). They will then undergo three vaccinations along with follow up clinic visits (which include evaluations and laboratory tests) to check their status.
The investigators learned that it was possible to generate an immune response in a subset of patients with malignant glioma. In addition, these cells were able to reach the brain and kill brain tumor cells. The survival of patients in this study was prolonged when compared to historical controls. Based on clinical data in subjects with brain tumors, the investigators believe that peripheral injection of dendritic cells will generate a more potent immune response for patients with brain stem gliomas and/or glioblastomas. The investigators hope to determine whether this therapy will translate into a longer survival and better quality of life in these patients in whom survival is measured in months. Through this study the investigators hope to learn more about the role of the body's immune response against cancer and about the use of dendritic cells for immunotherapy. This information may prove useful in the therapy of patients with glioblastoma and/or brainstem gliomas.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576641
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Surasak Phuphanich, M.D.||Cedars-Sinai Medical Center|