The main purpose of this institutional based protocol is to perform sentinel surveillance of designed study personnel exposure to the genetic material utilized in the clinical trial for treating melanoma. The safety of health care providers will be further insured by the preparation of the vaccine in a pharmaceutical laminar airflow biosafety cabinet. This precautionary measure will prevent aerosolized plasmid. The procedures will be performed by a designated nurse who will be serially monitored for anti B7-seroconversion and CTL assays. The designee will be evaluated for anti B7 antibody formation by ELISA every other month. Peripheral blood lymphocytes will be analyzed by CTL assays. In order to monitor germline integration in study patients, all sexually active study participants, as well as significant others, will be serially monitored. If sperm can be obtained, genomic DNA will be obtained and monitored for plasmid integration by PCR and Southern Blot technique. Patients, their partners, and health care providers will be required to sign a separate section added to the informed consent detailing the tests and procedures for this monitoring. The main purpose of this subject treatment based research is to evaluate the safety and efficacy of Allovectin-7 in combination with dacarbazine (DTIC) with the hope that a better response to treatment will occur. Participants in this research study have been diagnosed with stage III or IV metastatic melanoma and are candidates for chemotherapy. The study will evaluate the combined use of gene therapy and chemotherapy as a potential treatment for melanoma.
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