Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients With Newly Diagnosed Advanced Adenomas
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
研究概览
简要总结
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
详细描述
PRIMARY OBJECTIVES:
I. To compare the immunogenicity at week 12 of a MUC1 peptide vaccine with adjuvant (MUC1 peptide-poly-ICLC adjuvant vaccine) (administered at 0, 2, and 10 weeks) in participants with a history of an advanced adenoma, randomized to receive MUC1 peptide vaccine versus placebo.
SECONDARY OBJECTIVES:
I. To evaluate the ability of the vaccine to elicit a long-term memory response.
II. To compare the adenoma recurrence rate from surveillance exams occurring at least 1 year and up to 3 years after week 0 vaccine administration - MUC1 versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of at least one of the following conditions in the previous 12 months:
- •Colorectal adenoma(s) >= 1 cm in maximal diameter
- •Colorectal adenoma(s) with villous or tubulovillous histology
- •Colorectal adenoma(s) with high grade (severe) dysplasia
- •Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
- •Ability to understand and the willingness to sign a written informed consent document
- •Willingness to undergo screening tests and procedures
- •Willingness to provide blood samples for toxicity monitoring and research purposes
- •Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =< 7 days prior to registration/randomization for women of childbearing potential
- •Willingness to employ adequate contraception through week 53 of the study; note: women of childbearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry and for the period of active vaccination (through week 53); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her physician immediately
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- •Hemoglobin greater than 90% of the lower limit of institutional normal
- •Platelets >= 100 B/L (10^9/L)
- •White blood cell (WBC) > 2.5 B/L (10^9/L)
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
- •Alkaline phosphatase =< 1.5 x institutional upper limit of normal
- •Total bilirubin =< 1.5 x institutional upper limit of normal
- •Blood urea nitrogen (BUN) =< 1.5 x institutional upper limit of normal
- •Creatinine =< 1.5 x institutional upper limit of normal
- •Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =< 1:160, negative, or < 1.0
排除标准
- •History of any colorectal cancer
- •History of other malignancy =< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer
- •Presence of an active acute or chronic infection or uncontrolled illness including, but not limited to unstable congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Acquired immunosuppressive diseases such as active human immunodeficiency virus (HIV) infection or congenital diseases of immunity
- •History of heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC])
- •History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto's thyroiditis, or Grave's disease
- •Current or planned use of immunomodulators including: infliximab, 6-MP (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent
- •Pregnant women
- •Breastfeeding women
- •Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) >= 5; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =< 2 are eligible for enrollment; participants with NAS of 3-4 must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake)
- •Receiving any other investigational agent =< 3 months prior to registration/randomization, except innocuous agents with no known interaction with the study agent (e.g., standard dose multivitamins or topical agents for limited skin conditions)
- •Any use of oral corticosteroids =< 12 weeks prior to registration/randomization
研究组 & 干预措施
Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine)
Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine)
Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
干预措施: MUC1 Peptide-Poly-ICLC Vaccine (Biological)
Arm II (saline)
Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.
干预措施: Saline (Other)
Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine)
Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.
干预措施: Quality-of-Life Assessment (Other)
Arm II (saline)
Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (saline)
Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
时间窗: Week 0 to week 12
The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank-Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.
次要结局
- Number of Patients With at Least a 2-Fold Increase in the IgG Ratio(At 12 weeks)
- Adenoma Recurrence Rate(At least one year and up to 3 years)
- Booster Response(At week 55)
- Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site(Up to 55 weeks)
- Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)(Up to 55 weeks)