- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01720836
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
May 3, 2023 updated by: Olivera Finn
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julie Ward, RN, BSN
- Phone Number: 412-647-8583
- Email: wardj@upmc.edu
Study Contact Backup
- Name: Judy Forster, RN, BSN, BS
- Phone Number: 412-647-8579
- Email: forsterje@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC Hillman Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stage IB/II/IIIA
Resection and adjuvant chemotherapy followed by 3 cycles of 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.
|
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 IA or I/II NSCLC or neuroendocrine carcinoid tumor
Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunologic response
Time Frame: 2 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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-MUC1 immunity
Time Frame: 2 years
|
To assess spontaneous anti- MUC1 immunity in response to cancer prior to administration of the MUC1 vaccine
|
2 years
|
Association between baseline MUC1 immunity and vaccine
Time Frame: 2 years
|
To assess the association between baseline MUC1 immunity and vaccine - induced increases in anti MUC1 antibodies
|
2 years
|
Immunocompetence versus immunosuppression
Time Frame: 2 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)}
|
2 years
|
MUC1 associated safety
Time Frame: 2 years
|
To monitor adverse events associated with the study agents
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arjun Pennathur, MD, University of Pittsburgh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Anticipated)
July 1, 2024
Study Completion (Anticipated)
September 1, 2029
Study Registration Dates
First Submitted
October 31, 2012
First Submitted That Met QC Criteria
October 31, 2012
First Posted (Estimate)
November 2, 2012
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-094
- 902168 (Other Grant/Funding Number: V Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Craig L Slingluff, JrCompleted
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Craig L Slingluff, JrCelldex TherapeuticsCompleted
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-
Butantan InstituteUniversity of Sao Paulo; Hospital Universitario da USPCompleted
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Sinovac Biotech Co., LtdCompleted
-
University of OxfordMalaria Research and Training Center, Bamako, MaliRecruiting
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GlaxoSmithKlineCompletedMalaria | Malaria VaccinesGhana, Burkina Faso
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GlaxoSmithKlineIQVIA, USAActive, not recruitingChickenpoxTaiwan, Poland, United States, Estonia, Puerto Rico, Mexico