DOSE ESCALATION TRIAL OF 100AA SYNTHETIC MUCIN PEPTIDE PANCREATIC CANCER

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The objectives of this study will be: 1)The toxicity and safety of the synthetic mucin peptide vaccine. 2)Establishing a phase II dose for future studies. 3)To obtain qualitative and quantitative information on tumor behavior by PET scans in response to MUC-1 vaccination in locally advanced pancreatic cancer. 4)Objective evidence of tumor regression in locally advanced disease. 5)Evaluate the disease free survival in patients with locally advanced disease and overall survival of all patients. The 105aa MUC-1 vaccine has shown immunogenicity in pancreatic, breast and colon cancer. The 100aa MCU-1 vaccine to be used in this study is similar to the 105aa vaccine but has been refined without the terminal five amino acid sequence. The optimum dose and schedule of vaccine administration is not known. In this study the adjuvant will be SB-AS2 which has demonstrated immunostimulant properties. Unlike BCG which is associated with severe skin toxicity including ulceration in the majority of patients, SB-AS2 appears to cause much less skin toxicity. We propose to do a Phase I dose escalation study of the 100aa MUC-1 peptide admixed with SB-AS2, in pancreatic cancer as current therapies are of marginal benefit and such patients can be ethically considered for investigational therapy.