Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT01720836

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

Led by Olivera Finn · Updated on 2025-10-21

30

Participants Needed

1

Research Sites

1039 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

All subjects will receive the vaccine subcutaneously every 3 weeks x 3 with optional yearly booster vaccines up to and including 5 years post last vaccine for those patients who are confirmed responders to the vaccine . The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor
  • Disease stage IA(T1NO), IB (T2NO), II & IIIA (N2 negative), IIIA (N2+), or IIIB (N3+)
  • Stable disease at enrollment
  • Men and women aged 18 years or older
  • ECOG performance status 0-1
  • Between 4 to 24 weeks post-standard care treatment for current disease stage
  • Acceptable organ and marrow function including leukocytes > 3,000/µL, neutrophils > 1,500/µL, hemoglobin > 10 g/dL, platelets > 100,000/µL
  • Normal total bilirubin and creatinine within institutional limits or creatinine clearance > 60 mL/min/1.73 m2 if AST and ALT elevated
  • Willingness to use effective contraception during treatment and for 3 months after if of childbearing potential
Not Eligible

You will not qualify if you...

  • Receiving any other investigational agents
  • History of prior malignancy except non-melanoma skin cancer
  • Positive ANA titer above 1:160
  • Known Hepatitis B or C on immunomodulators
  • Prior vaccine therapy
  • Receiving steroids or other anti-immune therapy at registration
  • More than 24 weeks from standard care treatment
  • Post-obstructive pneumonia or serious infection at registration
  • Serious underlying medical conditions impairing ability to receive treatment
  • Less than five years since prior lung cancer resection
  • Uncontrolled illness including infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Pregnant women or positive pregnancy test
  • Known HIV-positive status
  • History of autoimmune disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Trial Site Locations

Total: 1 location

1

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

R

Research Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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