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

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Immunologic response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
Immunocompetence versus immunosuppression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
To monitor adverse events associated with the study agents
anti-MUC1 response association with recurrence or progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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:	November 2017
Estimated Primary Completion Date:	November 2017 (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 vaccination.	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 vaccination.	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 vaccination.	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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720836

Contacts

Contact: Julie Ward, RN, BSN	412-647-8583	wardj@upmc.edu
Contact: Judy Forster, RN, BSN, BS	412-647-8579	forsterje@upmc.edu

Locations

United States, Pennsylvania
UPMC Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

Olivera Finn

Investigators

Principal Investigator:

Benny Weksler, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Olivera Finn, Professor of Immunology, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01720836 History of Changes
Other Study ID Numbers:	11-094, 902168
Study First Received:	October 31, 2012
Last Updated:	November 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboxymethylcellulose Sodium

Poly I-C
Poly ICLC
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013