AUTOLOGOUS ACTIVATED MONOCYTES GIVEN I P FOR COLONIC CARCINOMATOSIS

自体激活单核细胞注射治疗结肠癌

• 批准号: 3896348
• 负责人: J W SMITH
• 金额: --
• 依托单位: DIVISION OF CANCER TREATMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3896348
• 关键词: carcinoma; human subject; human therapy evaluation; interferons; interleukin 2; leukocyte activation /transformation; monocyte; neoplasm /cancer immunotherapy; neoplasm /cancer surgery; passive immunization

Human monocytes that have been isolated and purified from the peripheral blood have been demonstrated to be capable of killing tumor targets in vitro following activation to cytotoxicity by interferon-gamma. The purpose of this study is to determine if autologous activated monocytes can be used as an effective form of adoptive immunotherapy for colon cancer patients with disease spread to the peritoneal cavity. This protocol is based on a previous BRMP protocol which employed a similar study design; however, the patient population had undergone laparotomy and complete surgical excision of all macroscopic tumor. The patients in that protocol tolerated leukapheresis and infusions of activated monocytes along with interferon-gamma with tolerable toxicity. This study will enroll patients who have measurable macroscopic disease to determine whether adoptively transferred activated monocytes have cytocidal activity against established tumor. Because the disease is limited to the peritoneal cavity, the infused monocytes will have adequate contact with the tumor deposits, and questions of trafficking should not complicate the analysis of their efficacy. Although the protocol has been open to patient entry for the past year, no patients were enrolled on the protocol due to the existence of a competing protocol using intraperitoneally administered interleukin-2 plus LAK cells. Now that protocol has been closed, it is expected that patient accrual will be significant for this study over the next two years.

人单核细胞是从 外周血已被证明能够杀死 体外肿瘤靶点激活细胞毒性后 干扰素-γ。 本研究的目的是确定是否 自体活化单核细胞可作为一种有效形式 结肠癌患者的过继免疫治疗 扩散至腹膜腔。 该协议基于 之前的 BRMP 方案采用了类似的研究设计； 然而，患者群体接受了剖腹手术并且 完全手术切除所有肉眼可见的肿瘤。 患者们 在该方案中，耐受白细胞分离术和活化的输注 单核细胞与干扰素-γ 一起具有可耐受的毒性。 这项研究将招募具有可测量的宏观 确定过继转移是否激活疾病 单核细胞对已形成的肿瘤具有杀细胞活性。 由于该病仅限于腹膜腔， 输注的单核细胞将与肿瘤充分接触 存款和贩运问题不应使问题复杂化 分析其功效。 尽管该协议过去一直对患者开放 年，由于以下原因，没有患者参加该方案 存在腹腔内使用的竞争方案 给予IL-2加LAK细胞。 现在该协议已 已关闭，预计患者应计将 对于未来两年的研究具有重要意义。