MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer

PRIMARY OBJECTIVES:

I. Immunogenicity of the vaccine, assessed at week 12, based on the increase in IgG anti‐MUC1
antibody titer over the pre‐vaccination levels.

II. Safety, assessed throughout the trial and continued observation for 24 weeks.

SECONDARY OBJECTIVES:

I. To explore potential differences, if any, in the immunogenicity of the vaccine (as
assessed at week 12 by the IgG anti‐MUC1 antibody titer ratio) in current versus (vs.) former
smokers.

II. To evaluate pre‐vaccination levels of circulating myeloid derived suppressor cells (MDSC)
and correlate with the ability to respond to the vaccine.

EXPLORATORY OBJECTIVES:

I. To explore immune response at week 24. II. To explore the relationship between chronic
obstructive pulmonary disease (COPD) status at pre‐registration and immune response in
current versus former smokers.

III. To explore the impact of the MUC1 peptide-Poly-ICLC vaccine (MUC1/Poly‐ICLC vaccine) on
inflammation‐related high sensitivity C-reactive protein (hsCRP) and interleukin‐6 (IL‐6)
levels.

IV. To explore the impact of baseline levels of hsCRP and IL‐6 on the ability to successfully
vaccinate with MUC1/Poly‐ICLC.

V. To establish a biospecimen repository archive: frozen peripheral blood live cells and
plasma for future more detailed and comprehensive immunologic assays, including direct
testing of anti‐MUC1 T cell immunity.

OUTLINE:

Patients receive MUC1 peptide-Poly-ICLC vaccine subcutaneously (SC) at weeks 0, 2, and 10.

After completion of study treatment, patients may be followed up at week 28.

Inclusion Criteria:

- PRE-REGISTRATION INCLUSION CRITERIA

- Smoking history of >= 30 pack‐years AND either current smoker (still smoking or quit <
1 year prior to pre‐registration) OR former smoker (quit 1‐15 years prior to
pre‐registration); Note: Pack years is determined by multiplying the number of packs
smoked per day by the number of years smoked

- Eastern Cooperative Oncology Group (ECOG) performance status =< 1

- Computed tomography (CT) scan of the chest done =< 6 months prior to pre‐registration
showing either negative findings (no nodules) or solid or part‐solid nodules < 6 mm in
size (consistent with < 1% probability of malignancy, Lung‐Reporting and Data Systems
[RADs] version 1.0)

- Willingness to employ adequate contraception, if applicable; Note: women of
child‐bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation; should a woman become pregnant or suspect she is pregnant
while participating in this study, she should inform her study physician immediately

- Ability to understand and the willingness to sign a written informed consent document

- REGISTRATION INCLUSION CRITERIA

- Leukocytes (white blood cell [WBC]) >= 3,000/microliter

- Neutrophils (absolute neutrophil count [ANC]) >= 1,500/microliter

- Platelets >= 100,000/microliter

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Note: Higher total
bilirubin levels (=< 3 mg/dL) can be allowed if due to known benign liver condition,
i.e. Gilbert's

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =<
1.5 x institutional upper limit of normal (ULN)

- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x
institutional upper limit of normal (ULN)

- Creatinine =< institutional upper limit of normal (ULN)

Exclusion Criteria:

- PRE-REGISTRATION EXCLUSION CRITERIA

- History of any malignancy; exceptions: non‐melanoma skin cancer or carcinoma in situ
(CIS) of the cervix

- Known hepatitis B or C

- Receiving any other investigational agents

- Any prior investigational immune therapy, such as for lung cancer prevention or
treatment or for CIS of the cervix

- Use of oral or systemic steroids or other systemic anti‐immune therapy =< 90 days
prior to pre-registration; Note: Use of inhaled/nasal steroids and local steroid
injections for pain control are not exclusionary

- Known human immunodeficiency virus (HIV)

- Known autoimmune disease

- Known non‐alcoholic steatohepatitis (NASH) or non‐alcoholic fatty liver disease
(NAFLD)

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to MUC1/Poly‐ICLC

- 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

- REGISTRATION EXCLUSION CRITERIA

- Positive antinuclear antibody (ANA) result

- Pregnant or breast feeding; breastfeeding should be discontinued if the mother is
treated with the vaccine