Pittsburgh, Pennsylvania 15232

  • small Cell Lung Cancer (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.


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 - No history of prior malignancy, except for non-melanoma skin cancer - 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


Study is Available At:


Original ID:

11-094


NCT ID:

NCT01720836


Secondary ID:

902168


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pittsburgh


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Arjun Pennathur, MD
Principal Investigator
University of Pittsburgh Medical Center
Primary Contact:Julie Ward, RN, BSN
412-647-8583
wardj@upmc.edu
Backup Contact:Judy Forster, RN, BSN, BS
412-647-8579
forsterje@upmc.edu

Study Dates

Start Date:November 2012
Completion Date:September 2022
Completion Type:Anticipated
Primary Completion Date:July 2022
Primary Completion Type:Anticipated
Verification Date:April 2020
Last Changed Date:April 2, 2020
First Received Date:October 31, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:MUC1 associated safety
Time Frame:2 years
Safety Issues:False
Description:To monitor adverse events associated with the study agents
Outcome Type:Secondary Outcome
Measure:Immunocompetence versus immunosuppression
Time Frame:2 years
Safety Issues:False
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 Suppre
Outcome Type:Secondary Outcome
Measure:Association between baseline MUC1 immunity and vaccine
Time Frame:2 years
Safety Issues:False
Description:To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
Outcome Type:Secondary Outcome
Measure:Anti-MUC1 immunity
Time Frame:2 years
Safety Issues:False
Description:To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine
Outcome Type:Primary Outcome
Measure:Immunologic response
Time Frame:2 years
Safety Issues:False
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.

Study Interventions

Intervention Type:Biological
Name:Vaccine + PolyICLC
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.
Arm Name:Stage IA or I/II NSCLC

Study Arms

Study Arm Type:Experimental
Arm Name:Stage IIIA or IIIB
Description:Concomitant chemo-irradiation followed by 3 cycles of vaccine + PolyICLC.
Study Arm Type:Experimental
Arm Name:Stage IB/II/IIIA
Description:Resection and adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.
Study Arm Type:Experimental
Arm Name:Stage IA or I/II NSCLC
Description:Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccine + PolyICLC.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Olivera Finn

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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