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

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。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。IDEC-159正在接受研究，作为一种单一疗法，用于治疗经病理证实的转移性结直肠腺癌，这些患者在接受或接受氟嘧啶、伊立替康和奥沙利铂化疗时没有反应或复发。在这项试验中，IDEC-159将标记有铟-111(111In)用于生物分布成像和剂量测定，或标记有Y-90(90Y)用于治疗。在研究的第一阶段，主要目标是确定90Y-IDEC-159的安全性并确定其MTD。第二个目标是评估活性；血液、正常器官和肿瘤剂量学；90Y-IDEC-159的免疫原性和药代动力学；以及它对可溶性TAG-72水平的影响。对于研究的第二阶段，主要目标是评估IDEC-159的安全性和活性。次要目标是评估血液、正常器官和肿瘤的剂量学；IDEC-159的免疫原性和药代动力学；以及它对TAG-72水平的影响。在第一阶段，受试者将按顺序剂量组分成3组或6组，直到MTD建立为止。一旦达到MTD，共有14名受试者(包括在MTD第一阶段登记的受试者)将被纳入和治疗。安全(血液学和化学)和活动评估将定期进行。

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.