TREATMENT PROTOCOL FOR ALLOVECTIN-7 IN METASTATIC CANCER BY DIRECT GENE TRANSFER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an extended protocol to allow subjects who have participated in the Vical 301 study and have had a tumor response to continue on treatment. This study will also allow subjects who have participated on the DTIC arm only in 301 to be able to get the gene therapy product Allovectin-7. Allovectin-7 is a gene therapy product containing the gene for the HLA-B7 protein. The HLA-B7 protein causes the cells which contain it to be recognized as a foreign invader by the immune system. The HLA-B7 gene is contained within the plasmid. These plasmids will be mixed with lipids and inserted into the tumor by needle injection. Once introduced into the tumor, the cells containing the plasmid DNA produce proteins which, based on animal studies, are thought to stimulate tumor tissue refection. This research study will be conducted at multiple sites across the country and will enroll approximately 12 subjects. This treatment requires injection of the gene substance directly into the subject's tumor(s). These gene injections are thought to induce an immune response to the cancer. The use of gene therapy immunotherapeutic, Allovectin-7, may provide a less toxic, but potentially equally effective alternative to the use of rINF and rIL-2 in a chemo-biotherapy combination therapy. Even if the rate of response were not to improve using Allovectin-7, the use of this immunotherapeutic in combination with DTIC may however, either extend the time to disease progression, or produce more durable responses resulting in tangible clinical benefit to patients.