Trial Information

Phase I Dose Escalation Trial of a 100 aa Synthetic Mucin Peptide Admixed With SB-AS2 as Adjuvant in Locally Advanced and Resected Pancreatic Cancer

OBJECTIVES: I. Determine the safety and toxicity of vaccination with MUC-1 antigen and
immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable
pancreatic cancer. II. Determine the maximum tolerated dose and/or recommended phase II dose
of MUC-1 antigen in this patient population. III. Determine the qualitative and quantitative
tumor response to this treatment in these patients. IV. Determine the disease-free survival
in resected patients, progression-free survival in locally advanced unresectable patients,
and overall survival in all patients receiving this treatment.

OUTLINE: This is a dose escalation study of MUC-1 antigen. Patients receive vaccination with
MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1. Treatment repeats
every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable
toxicity. Beginning 1 year after the last vaccination, patients without recurrent disease
may receive booster vaccines annually. Cohorts of 4 to 8 patients receive escalating doses
of MUC-1 antigen until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting
toxicity. Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.