Investigators at the UAB Cancer Center are currently looking into innovative treatments to improve the therapy of metastatic colon and rectal cancer using a form of gene therapy. This form of gene therapy utilizes the intramuscular injection of plasmid DNA which contains the gene for carcinoembryonic antigen (CEA), a tumor-associated antigen expressed on the surface of colorectal cancer cells. It is expected that a small fraction of muscle cells will express CEA and stimulate an immune response directed against tumor cells. This form of gene therapy is called a polynucleotide augmented anti-tumor immunization since the plasmid DNA injected into the muscle may induce an immune response to the CEA molecule. This polynucleotide augmented anti-tumor immunization to CEA antigen is an investigational treatment. The plasmid DNA also contains the gene for a viral protein from the hepatitis B virus. It is expected that a small fraction of muscle cells will express this viral protein and stimulate an immune response to hepatitis B. This gene therapy polynucleotide augmented anti-tumor immunization has been tested in animals and found to be safe and to induce anti-tumor effects. This type of therapy has not been given to patients previously so the side effets or toxicity are unknown. This trial will evaluate the side effects as well as the immunologic response to this experimental immunization therapy.
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