Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Olivera Finn
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Subjects may not be receiving any other investigational agents
- ✕ \- No history of prior malignancy, except for non-melanoma skin cancer
- ✕ Any positive 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.
- ✕ 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.
Where it's recruiting
Pittsburgh
Source: ClinicalTrials.gov · NCT01720836 · last updated 2025-10-21