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

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vaccine + PolyICLC
Sponsored by
Olivera Finn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UPMC Hillman Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor

Stage IB/II/IIIA

Stage IIIA or IIIB

Arm Description

Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.

Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.

Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.

Outcomes

Primary Outcome Measures

Immunologic response
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
To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine
Association between baseline MUC1 immunity and vaccine
To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
Immunocompetence versus immunosuppression
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
To monitor adverse events associated with the study agents

Full Information

First Posted
October 31, 2012
Last Updated
May 3, 2023
Sponsor
Olivera Finn
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1. Study Identification

Unique Protocol Identification Number
NCT01720836
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivera Finn

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage IA or I/II NSCLC or neuroendocrine carcinoid tumor
Arm Type
Experimental
Arm Description
Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Arm Title
Stage IB/II/IIIA
Arm Type
Experimental
Arm Description
Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Arm Title
Stage IIIA or IIIB
Arm Type
Experimental
Arm Description
Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
Intervention Type
Biological
Intervention Name(s)
Vaccine + PolyICLC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunologic response
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Anti-MUC1 immunity
Description
To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine
Time Frame
2 years
Title
Association between baseline MUC1 immunity and vaccine
Description
To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
Time Frame
2 years
Title
Immunocompetence versus immunosuppression
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)}
Time Frame
2 years
Title
MUC1 associated safety
Description
To monitor adverse events associated with the study agents
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or neuroendocrine carcinoid tumor 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 24 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 - 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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Ward, RN, BSN
Phone
412-647-8583
Email
wardj@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Forster, RN, BSN, BS
Phone
412-647-8579
Email
forsterje@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arjun Pennathur, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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