In this study, patients with advanced adenocarcinoma that reacts with NR-LU-10 monoclonal antibody will be treated with radioimmunotherapy using a pretargeting approach. Using this method, each patient will receive a total of three infusions. The first infusion will consist of NR-LU-10 monoclonal antibody/Streptavidin, followed by a clearing agent (Galactose-Biotin-Human Serum Albumin) to remove circulating unbound antibody, and lastly, 111In and 90Y-DOTA-Biotin. Patients will then be imaged in the anterior and posterior projections in a whole body mode immediately following injection and at three hours and one, two, and five days following treatment. Doses to tumor and normal tissue will be calculated from data obtained from the immunoscintigraphy studies as well as tumor and bone marrow biopsies in a subset of patients. A minimum of three patients will be treated at each dose level until the maximal tolerated dose is established. Tumor size measurements will be obtained whenever possible. Clinical efficacy will be assessed using a variety of imaging studies appropriate for the particular patients known/monitored sites of disease, as well as by serum tumor marker measurements when indicated. In addition, the incidence and timing of human anti-immunoconjugate antibody responses will be determined by ELISA assays. Pharmacokinetic profiles will be determined by measuring the levels of immunoconjugate in serum either by ELISA or RIA assays. The primary objectives of the study are to establish the MTD of 90Y-Biotin-DOTA when administered as part of a pretargeting approach to evaluate the safety of the pretargeting approach.
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