A Phase I/II Study of the Intralesional Injection of Ricin-Monoclonal Antibody Conjugates in Patients with Hepatic Metastases

摘要: A phase I/II study of the intralesional administration ricin-labelled monoclonal antibodies was conducted in patients with hepatic metastases gastrointestinal origin. The anti-carcinoembryonic antigen (CEA) antibody I-1 conjugated to blocked ricin via a disulphide bridge. After test dose antibody, were injected ricin-antibody conjugates under computed tomography (CT) guidance on two occasions 1 week apart. Patients stable or responding disease would receive third course. relative surface area increased predefined manner cohorts 3 patients. total 27 entered into this study. All had metastatic colorectal cancer (26 patients) adenocarcinoma unknown primary elevated CEA levels (1 patient). presence malignancy documented cytologically 9 11 tested. Minor responses seen 7 However, no major objective changes growth rate lesions observed. Toxicity generally mild, most common being capsular pain 24-48 h after each injection. 6 experienced rigors. One patient anaphylaxis. Human anti-mouse and anti-ricin Although substantial amounts delivered single lesions, therapeutic approach unsuccessful. Future studies should incorporate systemic immunoconjugates.