Lung Cancer Clinical Trial
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
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.
Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
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 16 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
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.
Subjects must not be more than 16 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
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There is 1 Location for this study
Pittsburgh Pennsylvania, 15232, United States
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