A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate safety/toxicity of Dendritic cell vaccine, Monitor survival and time to progression and monitor the cellular immune responses.
Surasak Phuphanich, M.D.
Cedars-Sinai Medical Center
United States: Food and Drug Administration
|Cedars Sinai Medical Center||Los Angeles, California 90048-1804|