Final results of the first phase I study of intraperitoneal administration of GL-ONC1, a marker gene modified vaccinia virus, in patients with peritoneal carcinomatosis
U Lauer, M Zimmermann, J Beil, S Berchtold, U Koppenhöfer, J Glatzle, A Königsrainer, R Möhle, D Nann, F Fend, C Pfannenberg, M Bitzer, N Malek · Zeitschrift für Gastroenterologie · 2015 · Heft 08
Bibliografische Angaben
Zusammenfassung
Introduction: We here report on our final results of a phase I study of intraperitoneal (i.p.) administration of the virotherapeutic drug GL-ONC1 in patients exhibiting advanced stage peritoneal carcinomatosis (PC). GL-ONC1 is a recombinant Vaccinia virus genetically engineered to selectively replicate in and destroy cancer cells. Methods: GL-ONC1 was administered i.p. every 4 weeks for up to 4 cycles at 3 different dose levels (10E7 – 10E9 pfu) following a standard 3 + 3 dose escalation design. GL-ONC1 was infused via an indwelling catheter which also enabled repetitive liquid (peritoneal fluid) biopsies and th…
