MUC1 Vaccine in Preventing Lung Cancer in Current and Former Smokers at High Risk for Lung Cancer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03300817|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Current Smoker Former Smoker||Other: Laboratory Biomarker Analysis Biological: MUC1 Peptide-Poly-ICLC Vaccine||Phase 1|
I. Immunogenicity of the vaccine, assessed at week 12, based on the increase in IgG anti‐MUC1 antibody titer over the pre‐vaccination levels.
II. Safety, assessed throughout the trial and continued observation for 24 weeks.
I. To explore potential differences, if any, in the immunogenicity of the vaccine (as assessed at week 12 by the IgG anti‐MUC1 antibody titer ratio) in current versus (vs.) former smokers.
II. To evaluate pre‐vaccination levels of circulating myeloid derived suppressor cells (MDSC) and correlate with the ability to respond to the vaccine.
I. To explore immune response at week 24. II. To explore the relationship between chronic obstructive pulmonary disease (COPD) status at pre‐registration and immune response in current versus former smokers.
III. To explore the impact of the MUC1 peptide-Poly-ICLC vaccine (MUC1/Poly‐ICLC vaccine) on inflammation‐related high sensitivity C-reactive protein (hsCRP) and interleukin‐6 (IL‐6) levels.
IV. To explore the impact of baseline levels of hsCRP and IL‐6 on the ability to successfully vaccinate with MUC1/Poly‐ICLC.
V. To establish a biospecimen repository archive: frozen peripheral blood live cells and plasma for future more detailed and comprehensive immunologic assays, including direct testing of anti‐MUC1 T cell immunity.
Patients receive MUC1 peptide-Poly-ICLC vaccine subcutaneously (SC) at weeks 0, 2, and 10.
After completion of study treatment, patients may be followed up at week 28.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of MUC1 Vaccine in Current and Former Smokers at High Risk for Lung Cancer|
|Actual Study Start Date :||December 27, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: Prevention (MUC1 peptide-Poly-ICLC vaccine)
Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.
Other: Laboratory Biomarker Analysis
Biological: MUC1 Peptide-Poly-ICLC Vaccine
- Immunogenicity of the MUC1 vaccine [ Time Frame: At week 12 ]Will be evaluated by monitoring changes in IgG anti‐MUC1 antibody titer ratio; defined as t12/t0, where t0 is the "initial titer" measured prior to vaccination, and t12 is the "final titer" drawn at 12 weeks. A titer ratio of >= 2 will be considered a positive response.
- Incidence of adverse events [ Time Frame: Up to week 24 ]Will be assessed according to National Cancer Institute Common Toxicity Criteria version 4.0. The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. In addition, the number and severity of adverse events will be tabulated and summarized across all grades.
- Differences in the immunogenicity of the vaccine [ Time Frame: Up to week 24 ]
- Pre‐vaccination levels versus post‐vaccination levels of circulating myeloid derived suppressor cells (MDSC) [ Time Frame: Up to week 12 ]Will correlate with the ability to respond to the vaccine. Will summarize the data using descriptive statistics and graphical methods (i.e. boxplots, scatter plots, etc.). For continuous MDSC data versus response data, will use t‐tests or Wilcoxon Rank‐Sum tests (for non‐normal data). For the associations of 2 continuous variables, will use linear regression, the correlation coefficient, and scatter plots.
- Chronic obstructive pulmonary disease (COPD) status [ Time Frame: Up to week 24 ]Will explore the relationship between COPD status at pre‐registration and immune response in current versus former smokers. In individuals with COPD, the severity of airflow obstruction will be measured by the pulmonary function tests as per the GOLD classification.
- Changes in immunogenicity in individuals with chronic obstructive pulmonary disease (COPD) [ Time Frame: Baseline up to week 24 ]Will explore whether or not changes in immunogenicity in individuals with COPD corresponds to different circulating MDSC levels.
- Impact of the MUC1/Poly‐ICLC vaccine on inflammation‐related high sensitivity C‐reactive protein (hsCRP) and interleukin‐6 (IL‐6) [ Time Frame: Up to week 24 ]
- Ability to successfully vaccinate with MUC1/Poly‐ICLC vaccine depending on baseline high sensitivity C‐reactive protein (hsCRP) and interleukin‐6 (IL‐6) levels [ Time Frame: Up to week 24 ]
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): NCT03300817
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Paul J. Limburg 507-284-2511 firstname.lastname@example.org|
|Principal Investigator: Paul J. Limburg|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Arjun Pennathur 412-648-6271 email@example.com|
|Principal Investigator: Arjun Pennathur|
|Principal Investigator:||Arjun Pennathur||Mayo Clinic|