临床试验/NCT03300817

NCT03300817进行中（未招募）1 期

A Pilot Study of MUC1 Vaccine in Current and Former Smokers at High Risk for Lung Cancer

National Cancer Institute (NCI)5 个研究点分布在 1 个国家目标入组 50 人开始时间: 2017年12月27日最近更新: 2026年7月31日

适应症

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: National Cancer Institute (NCI)
入组人数: 50
试验地点: 5
主要终点: Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This pilot phase I trial studies the side effects and how well MUC1 peptide-Poly-ICLC vaccine works in preventing lung cancer in current and former smokers at high risk for lung cancer. Vaccines made from peptides may help the body build an effective immune response to kill cells. MUC1 peptide-Poly-ICLC vaccine may stimulate the body's immune system and slow or stop the changes from normal to pre-cancer to cancer.

详细描述

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 55 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•PRE-REGISTRATION INCLUSION CRITERIA
•Smoking history of >= 30 pack-years AND either current smoker (still smoking or quit < 1 year prior to pre-registration) OR former smoker (quit 1-15 years prior to pre-registration); Note: Pack years is determined by multiplying the number of packs smoked per day by the number of years smoked
•Eastern Cooperative Oncology Group (ECOG) performance status =< 1
•Computed tomography (CT) scan of the chest done =< 6 months prior to pre-registration showing either negative findings (no nodules) or solid or part-solid nodules < 6 mm in size (consistent with < 1% probability of malignancy, Lung-Reporting and Data Systems [RADs] version 1.0)
•Willingness to employ adequate contraception, if applicable; Note: women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
•Ability to understand and the willingness to sign a written informed consent document
•REGISTRATION INCLUSION CRITERIA
•Leukocytes (white blood cell [WBC]) >= 3,000/microliter
•Neutrophils (absolute neutrophil count [ANC]) >= 1,500/microliter
•Platelets >= 100,000/microliter
•Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Note: Higher total bilirubin levels (=< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's
•Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 1.5 x institutional upper limit of normal (ULN)
•Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal (ULN)
•Creatinine =< institutional upper limit of normal (ULN)

排除标准

•PRE-REGISTRATION EXCLUSION CRITERIA
•History of any malignancy; exceptions: non-melanoma skin cancer or carcinoma in situ (CIS) of the cervix
•Known hepatitis B or C
•Receiving any other investigational agents
•Any prior investigational immune therapy, such as for lung cancer prevention or treatment or for CIS of the cervix
•Use of oral or systemic steroids or other systemic anti-immune therapy =< 90 days prior to pre-registration; Note: Use of inhaled/nasal steroids and local steroid injections for pain control are not exclusionary
•Known human immunodeficiency virus (HIV)
•Known autoimmune disease
•Known non-alcoholic steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD)
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to MUC1/Poly-ICLC
•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
•REGISTRATION EXCLUSION CRITERIA
•Any positive antinuclear antibody (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
•Pregnant or breast feeding; Note: Pregnant women are excluded from this study because the MUC1/Poly-ICLC vaccine may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with MUC1/Poly-ICLC vaccine, breastfeeding should be discontinued if the mother is treated with the vaccine

研究组 & 干预措施

Prevention (MUC1 peptide-Poly-ICLC vaccine)

Experimental

Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.

干预措施: Laboratory Biomarker Analysis (Other)

Prevention (MUC1 peptide-Poly-ICLC vaccine)

Experimental

Patients receive MUC1 peptide-Poly-ICLC vaccine SC at weeks 0, 2, and 10.

干预措施: MUC1 Peptide-Poly-ICLC Vaccine (Biological)

结局指标

主要结局

Count of Patients Experiencing 1 or More Grade 3+ Adverse Events at Least Possibly Related to Treatment

时间窗: 24 weeks

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.

Number of Participants With Immunogenicity of the MUC1 Vaccine

时间窗: 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.

次要结局

Pre-Vaccination Levels Versus Post-Vaccination Levels of Circulating Myeloid Derived Suppressor Cells (MDSC)(12 weeks)
Effect of Smoking Status on Vaccine Response(12 weeks)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (5)

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