Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
2019年1月3日 更新者：Robert Schoen
Study of the MUC1 Peptide - Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring.
MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is expressed in a larger amount and in a modified form on adenomatous polyps and colorectal cancer. These changes in MUC1 are thought to be part of the process of progression from adenomas toward cancer. The goal of a vaccine is to help the immune system in the body identify the changes in MUC1 that accompany the progression to cancer and eliminate the abnormal cells that make abnormal MUC1.
研究概览
详细说明
This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine among subjects at increased risk for colorectal cancer by virtue of a history of advanced adenoma.
The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1.
Among the secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced, has an effect on the recurrence of polyps.
Subjects with a history of advanced adenoma will be recruited for MUC1 vaccination.
Vaccine will be administered at weeks 0, 2, and 10.
Some subjects may have pre-existing immunity to MUC1, and this will be accounted for in the analytic phase.
However, all subjects will be administered the vaccine, regardless of baseline antibody status.
To insure accurate standardization in measurement and assessment of antibody levels, assays for baseline antibody status will be done at the same time as those for response to vaccine.
研究类型
介入性
注册 (实际的)
46
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- Digestive Disorders Clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
-Age 40 - 70 years of age.
History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
- Colorectal adenoma(s) ≥ 1 cm in maximal diameter
- Colorectal adenoma(s) with villous or tubulovillous histology
- Colorectal adenoma(s) with high-grade dysplasia
- Willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
- ECOG performance status 0 or 1
- Hemoglobin greater than 95% of the lower limit of institutional normal. Platelets ≥100,000/µL.
- AST (SGOT), ALT (SGPT), alkaline phosphatase, total bilirubin, BUN, creatinine ≤ 1.5x upper limit of institutional normal.
- ANA < 1:160
Exclusion Criteria:
- Receiving any other investigational agents.
- Presence of an active acute or chronic infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
- History of heritable cancer syndrome (FAP, HNPCC)
- Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- History of malignancy < 5 years prior to the Registration/Randomization evaluation, excluding non-melanoma skin cancer.
- Any use of oral corticosteroids ≤ 12 weeks prior to Registration/Randomization.
- Current or planned use of immunomodulators including: Remicade, 6-MP (Mercaptopurine), Methotrexate, cyclosporine, or other immunomodulatory drugs.
- Pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. Breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MUC1 Poly-ICLC
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The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic.
The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh.
The site of injection will remain the same thigh, to enhance the potential immune response.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Anti Muc-1 Antibody
大体时间：52 weeks
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Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
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52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Autoimmune Response to Muc-1 Vaccine
大体时间：52 weeks
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Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.
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52 weeks
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Number of Participants With Adverse Events Associated With the Study Agent
大体时间：54 weeks
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Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.
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54 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Robert E Schoen、University of Pittsburgh
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年10月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2008年10月15日
首先提交符合 QC 标准的
2008年10月15日
首次发布 (估计)
2008年10月16日
研究记录更新
最后更新发布 (实际的)
2019年1月7日
上次提交的符合 QC 标准的更新
2019年1月3日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
MUC1 - Poly ICLC的临床试验
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Shanghai 10th People's HospitalHangzhou NeoVax Biotechnology Co. LTD招聘中
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Jennie TaylorUniversity of Minnesota主动，不招人
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Ian F. Pollack, M.D.National Cancer Institute (NCI); Musella Foundation完全的
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Carolyn BrittenOncovir, Inc.完全的
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Immatics Biotechnologies GmbHBioNTech SE; University Hospital Tuebingen; BCN Peptides; EU-funded GAPVAC Consortium完全的
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Ludwig Institute for Cancer ResearchMemorial Sloan Kettering Cancer Center完全的