Last updated on March 2019

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


Brief description of study

This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine works in preventing lung cancer in current and former smokers at high risk for lung cancer. Vaccines made from peptides may help the body build an effective immune response to kill cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop the changes from normal to pre-cancer to cancer.

Detailed Study Description

PRIMARY OBJECTIVES:

I. Immunogenicity of the vaccine, assessed at week 12, based on the increase in IgG antiMUC1 antibody titer over the prevaccination 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 antiMUC1 antibody titer ratio) in current versus (vs.) former smokers.

II. To evaluate prevaccination 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 preregistration and immune response in current versus former smokers.

III. To explore the impact of the MUC1 peptide-Poly-ICLC vaccine (MUC1/PolyICLC vaccine) on inflammationrelated high sensitivity C-reactive protein (hsCRP) and interleukin6 (IL6) levels.

IV. To explore the impact of baseline levels of hsCRP and IL6 on the ability to successfully vaccinate with MUC1/PolyICLC.

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 antiMUC1 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.

Clinical Study Identifier: NCT03300817

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Mayo Clinic

Rochester, MN United States
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