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

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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.