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

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个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 研究中心，而研究中心不一定是研究者所在的机构。 这项研究的目的是找到最高剂量的吉西他滨药物，可以与一种称为放射性抗体（Y-90 anti-CEA）的研究药物一起使用，而不会引起无法控制的副作用，用于治疗晚期癌症（已扩散到身体远端部位的疾病）的受试者，这种癌症产生一种称为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（已经扩散到身体远处的疾病），如果手术或放射不再可能，治疗选择就有限了。全身治疗通常是首选的治疗策略。然而，在大多数情况下，使用这一战略的反应率是有限的，而且相对较短。因此，实验性治疗是必要的。CEA是一种存在于多种癌症中的蛋白质。在早期的研究中，CEA的抗体被证明可以找到并附着在含有CEA的肿瘤上。在某些情况下，将放射性粒子附着到抗CEA抗体上可以将足够的放射性引导到肿瘤上以帮助缩小肿瘤。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引起严重的副作用，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结果。吉西他滨是一种化疗药物，在实验室和患者中均显示出与辐射强烈相互作用的证据。

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.