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Radioimmunolocalization of Metastatic Breast Carcinoma Using Indium-111-Methyl Benzyl DTPA BrE-3 Monoclonal Antibody: Phase I Study

Division of Nuclear Medicine, Kaplan Comprehensive Cancer Center, Division of Oncology, Department of Pathology, NYU Medical Center/Bellevue Hospital Center, New York, New York
Department of Biology, New York University, New York, New York
Section of Radiodiagnosis and Therapy, University of California at Davis, Sacramento, California
Coulter Immunology, Hialeah, Florida
Cancer Research Fund of Contra Costa, Walnut Creek, California

Correspondence: For correspondence and reprints contact: Elissa Kramer, MD, Division of Nuclear Medicine HW215, NYU Medical Center, 560 First Ave., New York, NV 10016.

ABSTRACT

Pharmacokinetics of radiolabeled BrE-3 monoclonal antibody (Mab), reactive against a breast mucin epitope, were assessed in 15 patients with advanced breast cancer. Patients received 5 mCi (185 MBq) of ¹¹¹In-methyl benzyl isothiocyanate DTPA (MX-DTPA) conjugated BrE-3 Mab intravenously with total anti-body doses of 10, 50 or 100 mg. Serial quantitative imaging, blood and urine clearance were obtained to measure pharmacokinetics, assess tumor localization and estimate radiation dose. Organ function was followed to determine toxicity. Mild allergic reactions occurred in four patients. Eighty-six percent of 70 known lesions and 5 unsuspected lesions were detected by antibody imaging. Biexponential modeling of radiolabeled anti-body in serum showed a T_1/2 = 9.5 ± 2.7 hr and T_1/2ß = 56 ± 25.4 hr. Total urinary excretion averaged 35.5% ± 19.3% injected dose (ID) by Day 8. Quantitative imaging showed that 0.02-2.56 %ID localized in tumors. Extrapolating dosimetry from ¹¹¹In-MX-DTPA-BrE-3 to ⁹⁰Y-MX-DTPA-BrE-3, we estimate therapeutic radiation doses could be delivered to some tumors with tolerable toxicity.

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