PHASE II STUDY OF A HER-2/NEU INTRACELLULAR DOMAIN (ICD) PEPTIDE-BASED VACCINE

HER-2/NEU 细胞内域 (ICD) 肽疫苗的 II 期研究

• 批准号: 7603475
• 负责人: Mary L. Disis
• 金额: $ 0.06万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603475
• 关键词: Adjuvant; Autoimmune Process; Cancer Patient; Cardiotoxicity; Clinical; Clinical Trials Design; Computer Retrieval of Information on Scientific Projects Database; Cytotoxic T-Lymphocytes; Development; Disease; ERBB2 gene; Funding; Grant; Immune; Immunity; Immunotherapy; In Vitro; Institution; Mediating; No Evidence of Disease; Phase; Phase I Clinical Trials; Protein Overexpression; Recurrence; Research; Research Personnel; Resources; Safety; Source; Staging; Testing; Toxic effect; Trastuzumab; United States National Institutes of Health; Vaccinated; Vaccines; Woman; immunogenicity; improved; malignant breast neoplasm; neoplastic cell; peptide based vaccine; prevent; response; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The cytotoxic T lymphocyte (CTL) has been considered the primary immune effector involved in mediating an anti-tumor response. Recent studies have demonstrated that "sensitization" of HER2 overexpressing tumor cells with trastuzumab, in vitro, will enhance the function of CTL specific for HER2. We have completed a Phase I study of a HER2 peptide based vaccine in women with HER2 overexpressing breast cancers without toxicity, particularly autoimmune or cardiac toxicity. This proposal outlines a Phase II clinical trial designed to estimate survival in Stage IV HER2 positive breast cancer patients with no evidence of disease and receiving trastuzumab and a HER2 ICD peptide based vaccine. In addition to survival we will assess the safety of combined immunotherapy, the immunogenicity of the approach, and whether the development of HER2 specific immunity correlates with clinical response. If we find that vaccinating against breast cancer after optimal treatment prevents or slow disease recurrence resulting in improved survival, more universal vaccine approaches can be rapidly developed and tested for the adjuvant treatment of all breast cancers.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 细胞毒性 T 淋巴细胞 (CTL) 被认为是参与介导抗肿瘤反应的主要免疫效应器。 最近的研究表明，体外曲妥珠单抗对 HER2 过表达肿瘤细胞的“致敏”将增强 HER2 特异性 CTL 的功能。 我们已经完成了一项针对 HER2 肽疫苗的 I 期研究，该疫苗针对 HER2 过度表达的乳腺癌女性，且无毒性，特别是自身免疫或心脏毒性。 该提案概述了一项 II 期临床试验，旨在评估无疾病证据且接​​受曲妥珠单抗和 HER2 ICD 肽疫苗的 IV 期 HER2 阳性乳腺癌患者的生存率。 除了生存之外，我们还将评估联合免疫疗法的安全性、该方法的免疫原性以及 HER2 特异性免疫的发展是否与临床反应相关。 如果我们发现在最佳治疗后接种乳腺癌疫苗可以预防或减缓疾病复发，从而提高生存率，则可以快速开发和测试更通用的疫苗方法，用于所有乳腺癌的辅助治疗。