Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (polyinosinic-polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose) or HILTONOL™ Adjuvant Vaccine in Patients with Localized and Locally Advanced Non-Small Cell Lung Cancer
All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.
• Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor
• All subjects must have one of the following stages: Stage IA(T1NO); IB (T2NO), II \& IIIA (N2 negative); IIIA (N2+), IIIB (N3+)
• Patients must have stable disease at the time of enrollment
• Women and men at least 18 years of age
• ECOG performance status 0-1(Appendix A)
• Subjects must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease
• Subjects must have acceptable organ and marrow function as defined below:
‣ Leukocytes \> 3,000/µL
⁃ Absolute Neutrophils \> 1,500/µL
⁃ Hemoglobin \> 10 g/dL
⁃ Platelets \> 100,000/µL
⁃ Total Bilirubin within normal institutional limits
⁃ Creatinine within normal institutional limits OR
⁃ Creatinine clearance \> 60 mL/min/1.73 m2 for subjects with above normal AST and ALT with alkaline phosphatase within \< 1.5 times upper limit of normal
• The effects of a MUC1vaccine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men and women of childbearing potential must be willing to use effective contraception (hormonal barrier method of birth control; abstinence) while on study treatment and for at least 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately