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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项研究的目的是找到药物吉西他滨的最高剂量，该剂量可以与一种称为放射性抗体（Y-90抗CEA）的研究药物一起使用，而不会产生难以控制的副作用，以治疗晚期癌症（已经扩散到身体远处的疾病），这种癌症会产生一种叫做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（已经扩散到身体远处的疾病），如果手术或放疗不再可能，治疗选择是有限的。对整个身体的治疗通常是治疗策略的选择。然而，在大多数情况下，使用这种策略的响应率是有限的，而且持续时间相对较短。因此，实验治疗是必要的。CEA是一种存在于多种癌症中的蛋白质。在早期的研究中，一种针对CEA的抗体被证明可以发现并附着在含有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上，从而帮助肿瘤缩小。然而，在大多数情况下，很难引导足够的放射性来缩小肿瘤，而不会造成严重的副作用，如血细胞计数下降。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，放疗和化疗的组合与肿瘤相互作用，以改善各种癌症的治疗效果。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的强烈相互作用。

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.