IGF::OT::IGF RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MUC1 VACCINE IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED ADENOMA

MUC l is overexpressed and hypoglycosylated on premalignant lesions such as adenomatous polyps, and its expression is significantly greater with higher degrees of dysplasia. MUC l is functionally important in the maintenance of the malignant phenotype. Thus, induction of an immune response against MUC l in the setting of premalignancy, such as in patients with adenomatous polyps, may protect from polyp recurrence as well as from progression to cancer. This is a randomized, double-blind, placebo controlled phase II trial designed to elicit immune responses to abnormal MUCl. There are several components to this Phase II trial, but all are dependent on achieving the demonstration of an immune response to the initial series of vaccinations. Although each part will provide salient independent data on MUC l immunoprevention, if the vaccine is not found to be immunogenic, then the subsequent studies will not be performed.