We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720836
First Posted: November 2, 2012
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Olivera Finn, University of Pittsburgh
  Purpose
All subjects will receive the vaccine subcutaneously every 3 weeks x 3 and then every 3 months for 3 years. 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.

Condition Intervention Phase
Non-small Cell Lung Cancer (NSCLC) Biological: Vaccine + PolyICLC Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Olivera Finn, University of Pittsburgh:

Primary Outcome Measures:
  • Immunologic response [ Time Frame: 3 years ]
    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:
  • anti-MUC1 immunity [ Time Frame: 3 years ]
    To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine

  • Association between baseline MUC1 immunity and vaccine [ Time Frame: 3 years ]
    To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies

  • Immunocompetence versus immunosuppression [ Time Frame: 3 years ]
    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)}

  • MUC1 associated safety [ Time Frame: 3 years ]
    To monitor adverse events associated with the study agents

  • anti-MUC1 response association with recurrence or progression [ Time Frame: 3 years ]
    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


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage IA or I/II NSCLC
Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Biological: Vaccine + PolyICLC
The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.
Experimental: Stage IB/II/IIIA
Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Biological: Vaccine + PolyICLC
The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.
Experimental: Stage IIIA or IIIB
Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
Biological: Vaccine + PolyICLC
The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 6 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 6 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720836


Locations
United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Olivera Finn
Investigators
Principal Investigator: Arjun Pennathur, MD University of Pittsburgh
  More Information

Responsible Party: Olivera Finn, Professor of Immunology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01720836     History of Changes
Other Study ID Numbers: 11-094
902168 ( Other Grant/Funding Number: V Foundation )
First Submitted: October 31, 2012
First Posted: November 2, 2012
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Poly ICLC
Poly I-C
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Antiviral Agents
Anti-Infective Agents