临床试验/NCT00470574

NCT00470574已完成不适用

Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21

Memorial Sloan Kettering Cancer Center1 个研究点分布在 1 个国家目标入组 7 人开始时间: 2007年3月20日最近更新: 2020年11月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 7
试验地点: 1
主要终点: Safety

研究概览研究设计入排标准结局指标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 may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.

详细描述

OBJECTIVES:

Primary

Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
Determine the IgG and IgM antibody response to this regimen in these patients.
Determine the proportion of breast cancer cells expressing this antigen in these patients.

Secondary

Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 120 Years（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

结局指标

主要结局

Safety

时间窗: 2 years

Immune Response

时间窗: 2 years

次要结局

Presence of Circulating Tumor Cells(2 years)

研究者

发起方

Memorial Sloan Kettering Cancer Center

申办方类型

Other

责任方

Sponsor

研究点 (1)

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