A Phase I Trial Combining High-Dose 90Y-Labeled Humanized Anti-CEA Monoclonal Antibody with Doxorubicin and Peripheral Blood Stem Cell Rescue in Advanced Medullary Thyroid Cancer.

摘要

This trial determined the pharmacokinetics, dosimetry, and dose-limiting toxicity of (90)Y-hMN-14 IgG (humanized anticarcinoembryonic antigen [CEA, or CEACAM5] monoclonal antibody; labetuzumab), combined with doxorubicin and peripheral blood stem cell (PBSC) support in advanced medullary thyroid cancer (MTC) patients. METHODS: Fifteen patients received an infusion of (111)In-hMN-14 IgG. One to 2 wk later, 14 patients received (90)Y-hMN-14 IgG, starting at 740 MBq/m(2), followed 24 h later with a fixed intravenous bolus dose of doxorubicin (60 mg/m(2)). Preharvested PBSCs were reinfused when the (90)Y activity in the body was 2,000 cGy at an administered dose of