Randomized double-blind phase II survival study comparing immunization with the anti-idiotypic monoclonal antibody 105AD7 against placebo in advanced colorectal cancer.

摘要: The cancer vaccine 105AD7 is an anti-idiotypic monoclonal antibody that mimics the tumour-associated antigen 791T/gp72 (CD55, Decay Accelerating Factor) on colorectal cells. Phase I studies in patients with advanced disease confirmed non-toxic, and T cell responses could be generated. A prospective, randomized, double-blind, placebo-controlled survival study was performed. 162 were enrolled between April 1994 October 1996. Patients attended at trial entry, 6 12 weeks, where they received or placebo. Study groups comparable terms of patient demographics, time from diagnosis (277.1 v 278.6 days). Baseline similar, 50% having malignancy least 2 anatomic sites. Compliance treatment poor, only receiving 3 planned vaccinations. Median randomization date 124 184 days placebo arms respectively (P = 0.38), 456 486 0.82). vaccination does not prolong cancer. reasons for lack efficacy are unclear, but may reflect high tumour burden population, poor compliance immunization. Further should concentrate minimal residual disease.