MUC1 Vaccine for Lung Cancer

Phase 1

Waitlist Available

Led By Arjun Pennathur

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial looks at the side effects of a vaccine made from peptides that may help prevent lung cancer in smokers. The vaccine may stimulate the body's immune system to slow or stop the changes from normal to cancer.

Who is the study for?

This trial is for current or former smokers with a high risk of lung cancer, who have good physical health and normal organ function. Participants should not be pregnant, must agree to use contraception if necessary, and cannot have had any other cancers (with some exceptions), hepatitis B or C, HIV, certain liver diseases, strong allergic reactions to similar vaccines, uncontrolled illnesses that could affect the study's outcome, or autoimmune diseases.Check my eligibility

What is being tested?

The trial is testing a MUC1 peptide-Poly-ICLC vaccine designed to prevent lung cancer by helping the immune system fight off potential cancer cells. It's in an early phase to see how well it works and what side effects it might cause when given to people at high risk due to their smoking history.See study design

What are the potential side effects?

Potential side effects are not fully known since this is an early-phase trial but may include typical vaccine-related reactions such as soreness at the injection site, fever, fatigue or allergic responses. The body’s immune response could also potentially target healthy cells leading to unintended consequences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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I have smoked for 30 or more years and either currently smoke or quit within the last 15 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Number of Participants With Immunogenicity of the MUC1 Vaccine

Secondary outcome measures

Effect of Smoking Status on Vaccine Response

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

Other outcome measures

Ability to Successfully Vaccinate With MUC1/Poly-ICLC Vaccine Depending on Baseline High Sensitivity C-Reactive Protein (hsCRP) and Interleukin-6 (IL-6) Levels

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

Chronic Obstructive Pulmonary Disease (COPD) Status

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