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In Vitro Complex Formation and Biodistribution of Mouse Antitumor Monoclonal Antibody in Cancer Patients

Nuclear Medicine Department, Clinical Center, Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

Correspondence: For reprints contact: James C. Reynolds, MD, Nuclear Medicine Dept., National Institutes of Health, Bldg. 10, Room 1C401, 9000 Rockville Pike, Bethesda, MD 20892.

ABSTRACT

The serum clearance and biodistribution of a murine monoclonal antibody were compared to the in vitro complex formation of the antibody with patients' sera. Iodine-125-labeled 9.2.27, an anti-melanoma antibody, was incubated with sera from ten melanoma patients who had received 9.2.27 in an earlier study. Complexes were observed in all patients using size exclusion high performance liquid chromatography and complex formation was partially blocked by nonspecific murine antibody, suggesting the presence of human anti-murine antibody in serum. All patients subsequently underwent imaging studies with [¹³¹I] 9.2.27 given intravenously. The serum levels of the antibody obtained after the second administration were inversely correlated with the level of in vitro complex formation. Patients whose serum formed high levels of complex showed a rapid serum clearance, high hepatic uptake, and accelerated whole body clearance and urinary excretion of ¹³¹I. This suggests that in patients who receive repetitive administration of murine antibody the serum clearance rate and biodistribution of intravenously injected antibody are altered by antibody complex formation in the serum.

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