Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Prior treatment

• No prior vaccine therapy
• Patients may not be receiving any steroids or other anti-immune therapy at the time of registration.
• Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration

Other illness

• Subjects may not be receiving any other investigational agents
  • \- No history of prior malignancy, except for non-melanoma skin cancer
• Known Hepatitis B on immunomodulators (i.e. interferon)
• Known Hepatitis C on immunomodulators (i.e. interferon)
• Subjects must not be more than 24 weeks from standard of care treatment for their particular stage of disease
• Subjects must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the subjects to receive protocol treatment
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Subjects with immune deficiency are not expected to respond to the vaccine. Therefore, known HIV-positive patients are excluded from the study
• Subjects with a history of known autoimmune disease are excluded from this study

Other

• Any positive ANA titer above 1:160, even in an asymptomatic individual. Note:
  • Weakly positive ANA defined as ANA titers up to 1:160 maximum (≤ 1:160) will be acceptable in an asymptomatic individual who is otherwise eligible for the study.
• Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test

• 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