Clinical Trials /

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

NCT01720836

Description:

All subjects will receive the vaccine subcutaneously every 3 weeks x 3. 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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
  • Official Title: Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant Vaccine in Patients With Localized and Locally Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: 11-094
  • SECONDARY ID: 902168
  • NCT ID: NCT01720836

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
Vaccine + PolyICLCStage IA or I/II NSCLC

Purpose

All subjects will receive the vaccine subcutaneously every 3 weeks x 3. 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.

Trial Arms

NameTypeDescriptionInterventions
Stage IA or I/II NSCLCExperimentalResection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
  • Vaccine + PolyICLC
Stage IB/II/IIIAExperimentalResection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
  • Vaccine + PolyICLC
Stage IIIA or IIIBExperimentalConcomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
  • Vaccine + PolyICLC

Eligibility Criteria

        Inclusion Criteria:

          -  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 12 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 Criteria:

          -  Subjects may not be receiving any other investigational agents

          -  Positive ANA lab result

          -  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 12 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Immunologic response
Time Frame:2 years
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Anti-MUC1 immunity
Time Frame:2 years
Safety Issue:
Description:To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine
Measure:Association between baseline MUC1 immunity and vaccine
Time Frame:2 years
Safety Issue:
Description:To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
Measure:Immunocompetence versus immunosuppression
Time Frame:2 years
Safety Issue:
Description: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)}
Measure:MUC1 associated safety
Time Frame:2 years
Safety Issue:
Description:To monitor adverse events associated with the study agents

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Olivera Finn

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