A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

Abramson Cancer Center at Penn Medicine2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2005年1月最近更新: 2014年9月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Abramson Cancer Center at Penn Medicine
入组人数: 30
试验地点: 2

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Vaccines made from peptides and a person's white blood cells may help the body build an effective immune response to kill tumor cells. Injecting the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. Giving vaccine therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast.

PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.

详细描述

OBJECTIVES:

Primary

Determine the feasibility and safety of neoadjuvant ultrasound-guided intranodal vaccine therapy comprising autologous dendritic cells pulsed with recombinant HER2/neu peptides in patients with ductal carcinoma in situ of the breast.
Determine the sensitization of CD4+ and CD8+ T cells to HER2/neu in patients treated with this vaccine.
Determine clinical response in patients treated with this vaccine.

Secondary

Correlate post-vaccine sensitization of CD4+ and CD8+ T cells to HER2/neu with clinical response in patients treated with this vaccine.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究者

发起方

Abramson Cancer Center at Penn Medicine

申办方类型

Other

研究点 (2)

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