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

177LU-J591 治疗不依赖雄激素的转移性前列腺癌的 II 期试验

• 批准号: 7604180
• 负责人: David M. Nanus
• 金额: $ 0.35万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604180
• 关键词: Antibodies; Bone Marrow; Computer Retrieval of Information on Scientific Projects Database; Dose; Funding; Glutamate Carboxypeptidase II; Grant; Human; Incidence; Institution; J591 Monoclonal Antibody; Measurable Disease; Metastatic Prostate Cancer; Patients; Phase II Clinical Trials; Rate; Relative (related person); Research; Research Personnel; Resources; Site; Source; Survival Rate; Toxic effect; United States National Institutes of Health; androgen independent prostate cancer; bone imaging; cancer site; indexing; response; tumor

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这不一定是调查员的机构。 研究人员已经证明，针对前列腺特异性膜抗原（PSMA）的MAB J591成功地靶向了几乎所有患者的转移性前列腺癌部位。此外，他们定义了177LU-J591的MTD。 他们现在寻求在此剂量下研究该药物的初步疗效。 主要目标是定义PSA反应率和可测量的疾病反应率。 次要目标是：（1）定义PSA响应的持续时间，（2）定义可测量疾病反应的持续时间，（（3）定义人类抗J591抗体（HAHA）的发生率，（HAHA）的发生率，（4）比较血液学毒性相对于骨髓受累（骨scan index），（5）评估靶向率的患者（6）的毒性（4） 177LU-J591到已知的肿瘤部位。