This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The purpose of this study is to evaluate the safety of taking T cells (lymphocytes, a type of white blood cell) from patients' blood with a brain tumor called malignant glioma, modifying the DNA of these cells in the laboratory to kill glioma cells, growing the modified cells in large numbers in the laboratory, and then re-administering the modified T cells directly into the brain. This study will also try to determine if the reprogrammed T cells attack glioma cells in the brain. It is anticipated that participation in this study will last approximately six months from the time of enrollment. After treatment on this study is over, subjects will continue to be followed indefinitely. Many patients with malignant glioma respond to treatment (show no evidenceof disease on standard clinical tests) but then relapse (the tumor starts to grow again). The major reason why patients have disease relapse is the ability of some tumor cells to survive chemotherapy and/or radiation therapy. Additional ways of killing tumor cells that may be resistant to chemotherapy and radiation therapy may improve the outcome of treatment. A type of immune cell called a cytotoxic T lymphocyte (CTL) can be engineered to kill glioma cells in the laboratory. This is done by inserting a piece of DNA into the T cells that allows them to recognize glioma cells. From a single T cell (clone), genetically-modified T cells can be grown to large numbers in the laboratory. The treatment to be used in this study has never been used before in animals or humans, and it is not known whether these clones will kill glioma cells when administered back to patients. Because the safety of this treatment in humans is also not known, the genetically-modified T cell clones have been engineered to also include a gene (called HyTK) that will allow the T cells to be killed with the antiviral drug ganciclovir if the clones are causing any serious side effects.
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