Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma

Fred Hutchinson Cancer Center2 个研究点分布在 1 个国家目标入组 12 人开始时间: 2003年5月最近更新: 2015年10月1日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Fred Hutchinson Cancer Center
入组人数: 12
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: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.

详细描述

OBJECTIVES:

Primary

Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.
Determine the duration of in vivo persistence of these CTL clones in these patients.

Secondary

Determine the antitumor effect of this regimen in these patients.

研究设计

研究类型: Interventional
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 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

研究者

发起方

Fred Hutchinson Cancer Center

申办方类型

Other

研究点 (2)

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