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

NCT03300817 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 5 other identifiers: NCI-2017-01781N01-CN-2012-00042MAY2016-08-01N01CN00042P30CA015083
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Immunogenicity of the MUC1 Vaccine

  Will be evaluated by monitoring changes in IgG anti-MUC1 antibody titer ratio; defined as t12/t0, where t0 is the "initial titer" measured prior to vaccination, and t12 is the "final titer" drawn at 12 weeks. A titer ratio of \>= 2 will be considered a positive response.

  At week 12

• Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment

  Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.

  24 weeks

Secondary Outcomes (2)

• Effect of Smoking Status on Vaccine Response

  12 weeks

• Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)

  12 weeks

Other Outcomes (4)

• Chronic Obstructive Pulmonary Disease (COPD) Status

  Baseline to week 12

• Changes in Immunogenicity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)

  Baseline up to week 12

• Impact of the MUC1/Poly-ICLC Vaccine on Inflammation-Related High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6)

  Up to week 24

Study Arms (1)

Prevention (MUC1 peptide-Poly-ICLC vaccine)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Biological: MUC1 Peptide-Poly-ICLC Vaccine

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Prevention (MUC1 peptide-Poly-ICLC vaccine)

MUC1 Peptide-Poly-ICLC Vaccine BIOLOGICAL

Given SC

Prevention (MUC1 peptide-Poly-ICLC vaccine)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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
• Any positive antinuclear antibody (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 or breast feeding; Note: Pregnant women are excluded from this study because the MUC1/Poly-ICLC vaccine may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with MUC1/Poly-ICLC vaccine, breastfeeding should be discontinued if the mother is treated with the vaccine

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Paul J. Limburg, M.D., M.P.H.
• Organization: Mayo Clinic

limburg.paul@mayo.edu

507-284-2511

Study Officials

• Arjun Pennathur

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 4, 2017
• Study Start: December 27, 2017
• Primary Completion: September 23, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026
• Results First Posted: April 19, 2023

Record last verified: 2025-12

Locations

US (2)