PHASE II TRIAL OF 177LU-J591 IN METASTATIC, ANDROGEN-INDEPENDENT PROSTATE CANCER

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 研究人员已经证明，针对前列腺特异性膜抗原(PSMA)的单抗J591可以成功地靶向几乎所有患者的前列腺癌转移部位。此外，他们还定义了177 Lu-J591的MTD。他们现在试图研究这种药物在这个剂量下的初步疗效。主要目标是定义PSA应答率和可测量的疾病应答率。次要目标是：(1)定义PSA应答的持续时间，(2)定义可测量的疾病应答的持续时间，(3)确定人类抗J591抗体(HAHA)应答的发生率，(4)比较血液学毒性与骨髓受累的相关性(骨扫描指数)，(5)评估患者治疗后的存活率，以及(6)确认177Lu-J591针对已知肿瘤部位的靶向。

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. The investigators have demonstrated that mAB J591, directed to prostate-specific membrane antigen (PSMA), sucessfully targets metastatic prostate cancer sites in virtually all patients. Furthermore, they have defined the MTD of 177Lu-J591. They now seek to study the preliminary efficacy of this agent at this dose. Primary Objectives are to define the PSA response rate, and the measurable disease response rate. Secondary Objectives are to: (1) define the duration of PSA response, (2) define the duration of measurable disease response, (3) define the incidence of human anti-J591 antibody (HAHA) response, (4) compare hematological toxicity relative to bone marrow involvment (bone scan index), (5) assess the survival rate of patients following treatment, and (6) confirm the targeting of 177Lu-J591 to known tumor sites.