临床试验/NCT00503568

NCT00503568已完成1 期

Novel Tumor Vaccine gp96-Ig Fusion Protein in Advanced (Stage IIIB), Relapsed or Metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) Patients Who Have Failed First Line Chemotherapy

University of Miami2 个研究点分布在 1 个国家目标入组 19 人开始时间: 2007年5月最近更新: 2016年12月15日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: University of Miami
入组人数: 19
试验地点: 2
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 made from a person's tumor cells may help the body build an effective immune response to kill non-small cell lung cancer cells.

PURPOSE: This phase I trial is studying the effects of gp96-Ig vaccine therapy in treating patients with stage III, stage IV, or relapsed non-small cell lung cancer treated with first-line chemotherapy.

详细描述

Overall Goals:

to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.

Primary Aim:

to evaluate the safety of administering a heat shock protein gp96-Ig-secreting allogeneic tumor cell-vaccine (gp96-Ig vaccine) in patients with advanced NSCLC.

Secondary Aims:

研究设计

研究类型: Interventional
分配方式: Non Randomized
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 —（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: 6, 12, 18, 24, and 36 months post enrollment

次要结局

Immunologic response: CD8, CD4 and NK response(Baseline, Day 1 Week1, Day 1 Week 13, Day 1 Week 19)

研究者

发起方

University of Miami

申办方类型

Other

责任方

Sponsor

研究点 (2)

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