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MUC1 Peptide Vaccine for Non-Small Cell Lung Cancer

This study is testing a vaccine called MUC1 100mer peptide, combined with Hiltonol®, for people with non-small cell lung cancer (NSCLC). Researchers want to see if this vaccine can create an immune response against the cancer. You might be able to join if you are at least 18 years old and have NSCLC or neuroendocrine carcinoid tumor at certain stages, and your disease is stable. The study aims to enroll 30 participants. The main goal is to measure your immune response to the vaccine after 2 years. Similar vaccines have shown no side effects and good immune responses in other studies.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
You will receive the vaccine under your skin every 3 weeks for 3 doses. You may also receive optional yearly booster vaccines for up to 5 years if you respond well to the vaccine.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured at 2 years after starting the study. Some participants may receive booster vaccines for up to 5 years.

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NCT01720836

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Olivera Finn
~30 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:Vaccine + PolyICLC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immunologic response
Measured over 2 years

Conditions

Non-small Cell Lung Cancer (NSCLC)

Explore related trials

Lung Non-Small Cell CarcinomaNeuroendocrine Carcinoid Tumor

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Arjun Pennathur, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh Medical Center

Who to contact

Research Coordinator
[email protected]
412-647-8583
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Subjects may not be receiving any other investigational agents
Any positive ANA titer above 1:160, even in an asymptomatic individual. Note:
Known Hepatitis B on immunomodulators (i.e. interferon)
Known Hepatitis C on immunomodulators (i.e. interferon)
No prior vaccine therapy
Patients may not be receiving any steroids or other anti-immune therapy at the time of registration.
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
Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration
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
Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test
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

What this trial measures

  • Immunologic response2 years

    Immunologic response will be measured by increases in anti MUC1 antibody titers post vaccination at different stages of disease: localized (Stage I, II) or locally advanced (Stage III) non-small cell lung cancer and neuroendocrine carcinoid tumors.