Vaccine Therapy in Treating Patients With Stage 0-III Non-Small Cell Lung Cancer or Neuroendocrine Carcinoid Cancer
This phase I/II trial studies the best way to give vaccine therapy and to see how well it works in treating patients with stage 0-III non-small cell lung cancer or neuroendocrine carcinoid cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
Inclusion Criteria
- Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC), neuroendocrine carcinoid tumors
- All subjects must have one of the following stages: Any stage 0, I, II or III
- Patients must have stable disease at the time of enrollment
- Women and men at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Subjects must be within 4 to 24 weeks of standard of care treatment for their particular stage of disease
- Leukocytes > 3,000/uL
- Absolute neutrophils > 1,500/uL
- Hemoglobin > 10 g/dL
- Platelets > 100,000/uL
- Total bilirubin within normal institutional limits
- Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for subjects with above normal aspartate aminotransferase (AST) and alanine aminotransferase (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 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 Criteria
- Subjects may not be receiving any other investigational agents
- No prior history of any malignancy, except for non-melanoma skin cancer
- Known Hepatitis B on immunomodulators(i.e. interferon)
- Known Hepatitis C on immunomodulators (i.e. interferon)
- 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. No prior vaccine therapy
- 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
- Known human immunodeficiency virus (HIV)-positive patients are excluded from the study
- Subjects with a history of known autoimmune disease are excluded from this study
Additional locations may be listed on ClinicalTrials.gov for NCT01720836.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
PRIMARY OBJECTIVES:
I. To evaluate the immunologic response to the MUC1 100mer peptide plus adjuvant, polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethyl cellulose (Poly-ICLC) (MUC1 peptide-poly-ICLC adjuvant vaccine) in non-small cell lung cancer and neuroendocrine carcinoid subjects.
II. To assess the dependence of response upon disease stage.
SECONDARY OBJECTIVES:
I. To assess spontaneous anti-mucin 1 (MUC1) immunity in response to cancer prior to administration of the MUC1 vaccine.
II. To assess the association between baseline MUC1 immunity and vaccine – induced increases in anti MUC1 antibodies.
III. To characterize the change in the balance between immunocompetence (response of T cells to polyclonal stimulation) versus immunosuppression at different stages of disease (check for increased numbers of regulatory T cells [Treg] and myeloid-derived suppressor cells [MDSC]).
IV. To monitor adverse events associated with the study agents.
V. To evaluate the association between the anti-MUC1 response (preexistent and/or induced or boosted by the vaccine) and recurrence or progression of lung cancer.
OUTLINE:
Patients receive MUC1 peptide-poly-ICLC adjuvant vaccine subcutaneously (SC) on weeks 0, 3, and 6. Patients may receive booster vaccine injections beginning 1 year post week 6 every year for 5 years. Patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 7 days. Patients undergoing optional boosters are followed up at 2 weeks.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorArjun Pennathur
- Primary IDHCC 11-094
- Secondary IDsNCI-2013-00081
- ClinicalTrials.gov IDNCT01720836