UAB 0472 - STUDY OF 90Y-LABELED IDEC-159

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。在更晚期的结直肠癌中，存活率下降，复发或转移性疾病的治疗仍然存在问题。正在研究IDEC-159作为经病理学证实的转移性结直肠腺癌的单药治疗，用于正在接受或接受氟尿嘧啶、伊立替康和奥沙利铂化疗期间无应答或复发的受试者。在本试验中，IDEC-159将用铟-111（111 In）标记用于生物分布成像和剂量测定，或用钇-90（90 Y）标记用于治疗。对于研究的I期部分，主要目的是表征90 Y-IDEC-159的安全性特征并确定MTD。次要目的是评价90 Y-IDEC-159的活性;血液、正常器官和肿瘤剂量测定;免疫原性和药代动力学;及其对可溶性TAG-72水平的影响。对于研究的II期部分，主要目的是评价IDEC-159的安全性和活性。次要目的是评价血液、正常器官和肿瘤剂量学; IDEC-159的免疫原性和药代动力学;及其对TAG-72水平的影响。在I期研究中，受试者将入组3或6个队列的序贯剂量组，直至确定MTD。一旦达到MTD，将入组和治疗总共14例受试者（包括I期部分中以MTD入组的受试者）。将定期进行安全性（血液学和化学）和活性评估。

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. In more advanced stages of colorectal cancer, survival rates decrease, with treatment of recurrent or metastatic disease remaining problematic. IDEC-159 is under investigation as a monotherapy treatment of pathologically confirmed metastatic colorectal adenocarcinoma in subjects that have failed to respond or relapsed while on or following fluoropyrimidine, irinotecan and oxaliplatin chemotherapy. In this trial, IDEC-159 will be labeled with indium-111 (111In) for biodistribution imaging and dosimetry, or with yttrium-90 (90Y) for therapy. For the Phase I portion of the study, the primary objective is to characterize the safety profile and determine the MTD of 90Y-IDEC-159 . The secondary objectives are to evaluate activity; blood, normal organ, and tumor dosimetry; immunogenicity and pharmacokinetics of 90Y-IDEC-159; and its effect on soluble TAG-72 levels. For the Phase II portion of the study, the primary objective is to evaluate the safety and activity of IDEC-159. Secondary objectives are to evaluate blood, normal organ, and tumor dosimetry; immunogenicity and pharmacokinetics of IDEC-159; and its effect on TAG-72 levels. In Phase I, subjects will be enrolled in cohorts of 3 or 6 in sequential dose groups until an MTD is established. Once the MTD is reached, a total of 14 subjects (including those enrolled at the MTD in the Phase I portion) will be enrolled and treated. Safety (hematology and chemistry) and activity assessments will occur at regular intervals.