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

通过直接基因转移治疗转移性癌症的 ALLOVECTIN-7 方案

• 批准号: 7376318
• 负责人: PAUL O SCHWARZENBERGER
• 金额: $ 0.19万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376318
• 关键词: TREATMENT; PROTOCOL; ALLOVECTIN; METASTATIC; CANCER; TREATMENT; PROTOCOL; ALLOVECTIN; METASTATIC; CANCER

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这是一个扩展的方案，允许参加Vical 301研究并进行肿瘤反应以继续治疗的受试者。这项研究还将允许仅在301中参加DTIT ARM的受试者能够获得基因治疗产品Allovectin-7。 Arovectin-7是一种含有HLA-B7蛋白基因的基因治疗产物。 HLA-B7蛋白会导致免疫系统识别为外国入侵者的细胞。 HLA-B7基因包含在质粒中。这些质粒将与脂质混合，并通过针注射将其插入肿瘤中。一旦引入肿瘤，含有质粒DNA的细胞会产生蛋白质，基于动物研究，被认为可以刺激肿瘤组织的反射。这项研究将在全国各地的多个地点进行，并将注册约12名受试者。这种治疗需要将基因物质直接注射到受试者的肿瘤中。这些基因注射被认为会引起对癌症的免疫反应。 使用基因治疗免疫治疗性分析蛋白7可能会提供毒性较小但具有同等有效的替代方法，可在化学生物疗法组合疗法中使用RINF和RIL-2。但是，即使使用Arlovectin-7的响应速率不改善，但使用该免疫治疗剂与DTIC结合使用，可以将时间延长到疾病进展的时间，或者产生更耐用的反应，从而对患者产生切实的临床益处。