MUC1 Vaccine in Patients with Newly Diagnosed Advanced Adenomas

MUC1 疫苗用于新诊断的晚期腺瘤患者

• 批准号: 8762914
• 负责人: Michael Pawlita
• 金额: $ 93.95万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-06 至 2016-01-05
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8762914
• 关键词: Address; Adenomatous Polyps; Adjuvant; Adverse event; Antibodies; Clinical Trials Design; Data; Double-Blind Method; Dysplasia; Immune response; Lesion; Maintenance; Malignant Neoplasms; Mucin-1 Staining Method; Myelogenous; Newly Diagnosed; Participant; Patients; Peptide Vaccines; Phase II Clinical Trials; Placebo Control; Placebos; Polyps; Premalignant; Randomized; Recording of previous events; Recurrence; Suppressor-Effector T-Lymphocytes; Vaccinated; Vaccines; Work; adenoma; immunogenic; immunogenicity; malignant phenotype; overexpression

MUC1 is overexpressed and hypoglycosylated on premalignant lesions such as adenomatous polyps, and its expression is significantly greater with higher degrees of dysplasia. MUC1 is functionally important in the maintenance of the malignant phenotype. Thus, induction of an immune response against MUC1 in the setting of premalignancy, such as in patients with adenomatous polyps, may protect from polyp recurrence as well as from progression to cancer. This is a randomized, double-blind, placebo controlled phase II trial designed to elicit immune responses to abnormal MUC1. There are 3 parts to this Phase II trial, but parts 2 and 3 are dependent on achieving the aims of part 1 (demonstration of an immune response to the vaccine). Although each part will provide salient independent data on MUC1 immunoprevention, but if the vaccine is not found to be immunogenic in part 1, then parts 2 and 3 will not be performed. Therefore, this statement of work only outlines the requirements for Part 1. If the aims of part 1 are achieved, a subsequent new statement of work will address parts 2 and 3.

MUC1在癌前病变如腺瘤性息肉中过度表达和低糖基化，并且其表达在高度异型增生中显著增加。MUC1在维持恶性表型中具有重要的功能。因此，在癌前病变的情况下，例如在腺瘤性息肉患者中，诱导针对MUC1的免疫应答可以防止息肉复发以及防止进展为癌症。 这是一项随机、双盲、安慰剂对照的II期试验，旨在引发对异常MUC1的免疫应答。本II期试验分为3个部分，但第2部分和第3部分取决于实现第1部分的目标（证明对疫苗的免疫应答）。虽然每个部分将提供关于MUC1免疫预防的显著独立数据，但如果在第1部分中未发现疫苗具有免疫原性，则将不进行第2和第3部分。因此，本工作说明书仅概述第1部分的要求。如果第一部分的目标得以实现，下一份新的工作说明将涉及第二和第三部分。