%0 Journal Article
%T LICC: L-BLP25 in patients with colorectal carcinoma after curative resection of hepatic metastases--a randomized, placebo-controlled, multicenter, multinational, double-blinded phase II trial
%A Carl Schimanski
%A Markus M£¿hler
%A Michael Sch£¿n
%A Eric van Cutsem
%A Richard Greil
%A Wolf Bechstein
%A Susanna Hegewisch-Becker
%A G£¿tz von Wichert
%A Matthias V£¿hringer
%A Michael Heike
%A Volker Heinemann
%A Marc Peeters
%A Stephan Kanzler
%A Stefan Kasper
%A Friedrich Overkamp
%A Jan Schr£¿der
%A Daniel Seehofer
%A Frank Kullmann
%A Bernhard Linz
%A Irene Schmidtmann
%A Victoria Smith-Machnow
%A Ines Gockel
%A Hauke Lang
%A Peter R Galle
%J BMC Cancer
%D 2012
%I BioMed Central
%R 10.1186/1471-2407-12-144
%X This is a multinational, phase II, multicenter, randomized, double-blind, placebo-controlled trial with a sample size of 159 patients from 20 centers in 3 countries. Patients with stage IV colorectal adenocarcinoma limited to liver metastases are included. Following curative-intent complete resection of the primary tumor and of all synchronous/metachronous metastases, eligible patients are randomized 2:1 to receive either L-BLP25 or placebo. Those allocated to L-BLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first L-BLP25 dose, then primary treatment with s.c. L-BLP25 930 ¦Ìg once weekly for 8 weeks, followed by s.c. L-BLP25 930 ¦Ìg maintenance doses at 6-week (years 1&2) and 12-week (year 3) intervals unless recurrence occurs. In the control arm, CP is replaced by saline solution and L-BLP25 by placebo. Primary endpoint is the comparison of recurrence-free survival (RFS) time between groups. Secondary endpoints are overall survival (OS) time, safety, tolerability, RFS/OS in MUC-1 positive cancers. Exploratory immune response analyses are planned. The primary endpoint will be assessed in Q3 2016. Follow-up will end Q3 2017. Interim analyses are not planned.The design and implementation of such a vaccination study in colorectal cancer is feasible. The study will provide recurrence-free and overall survival rates of groups in an unbiased fashion.EudraCT Number 2011-000218-20The primary objective of the ongoing LICC trial (L-BLP25 In Colorectal Cancer) is to determine whether L-BLP25, an active cancer immunotherapy, extends recurrence-free survival (RFS) time over placebo in colorectal cancer pts following R0/R1 resection of hepatic metastases. Stimuvax£¿ (BLP25 Liposome Vaccine or L-BLP25) is an investigational therapeutic cancer vaccine co-developed by Oncothyreon Canada Inc. (formerly Biomira Inc., Edmonton, Canada), and Merck KGaA, Darmstadt, Germany for the use as an active specific immunotherapy for MUC1- expressing tumors. Details of t
%U http://www.biomedcentral.com/1471-2407/12/144