A PHASE I STUDY OF A COMBINATION OF YTTRIUM-90 LABELED ANTI-CEA ANTIBODY

钇 90 标记的抗 CEA 抗体组合的 I 期研究

• 批准号: 7368156
• 负责人: Stephen I Shibata
• 金额: $ 3.7万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 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/7368156
• 关键词: PHASE; STUDY; COMBINATION; YTTRIUM; 90

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 purpose of this research study is to find the highest dose of the drug gemcitabine that can be given with an investigational drug called a radioactive antibody (Y-90 anti-CEA) without causing unmanageable side effects, to treat subjects with advanced cancer (disease that has spread to distant parts of the body) that produces a substance called CEA (carcinoembryonic antigen). An additional purpose is to estimate the radiation dose of Y-90 anti CEA to the whole body, organs and tumor. For most advanced cancers (disease that has spread to distant parts of the body), treatment options are limited if surgery or radiation is no longer possible. Therapy for the entire body is usually the treatment strategy of choice. However, in most cases response rates using this strategy are limited and relatively short lived. Experimental treatments are therefore necessary. CEA is a protein that is present in a variety of cancers. In earlier studies, an antibody to CEA was shown to find and attach to tumors that contain CEA. In some cases attaching a radioactive particle to anti-CEA antibody can direct enough radioactivity to the tumor to help shrink it. In most cases, however, it is difficult to direct enough radioactivity to shrink the tumor without causing severe side effects such as decreased blood counts. It is possible that giving both a radioactive antibody and a chemotherapy drug may lead to more effective treatment. Clinical trials have shown that combinations of radiation and chemotherapy interact with the tumor to improve treatment results in a variety of cancers. Gemcitabine is a chemotherapy drug that has shown evidence of strong interaction with radiation both in the laboratory and in patients.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是寻找与一种名为放射性抗体(Y-90抗CEA)的研究药物一起服用的最高剂量的药物吉西他滨，而不会引起无法控制的副作用，用于治疗晚期癌症(已扩散到身体远处的疾病)，并产生一种名为CEA(癌胚抗原)的物质。另一个目的是估计Y-90抗CEA对全身、器官和肿瘤的辐射剂量。对于大多数晚期癌症(已扩散到身体远处的疾病)，如果不再可能进行手术或放射治疗，治疗选择是有限的。全身治疗通常是治疗策略的选择。然而，在大多数情况下，使用这一策略的响应率是有限的，并且相对较短。因此，试验性治疗是必要的。CEA是一种存在于多种癌症中的蛋白质。在早期的研究中，发现了一种CEA抗体，并将其附着到含有CEA的肿瘤上。在某些情况下，将放射性粒子附着在抗CEA抗体上可以将足够的放射性引导到肿瘤，以帮助缩小它。然而，在大多数情况下，很难在不引起血细胞减少等严重副作用的情况下引导足够的放射性来缩小肿瘤。同时给予放射性抗体和化疗药物可能会导致更有效的治疗。临床试验表明，放射和化疗的组合与肿瘤相互作用，以改善各种癌症的治疗结果。吉西他滨是一种化疗药物，在实验室和患者身上都显示出与辐射强烈相互作用的证据。