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临床试验/NCT00616291
NCT00616291已完成1 期

Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2006年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
14
试验地点
2
主要终点
Tolerability

研究概览

简要总结

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.

详细描述

OBJECTIVES:

Primary

  • Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.

Secondary

  • Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.
  • Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.
  • Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Tolerability

Toxicity

次要结局

  • Immunological response

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Hayes

Associate Professor

Baylor College of Medicine

研究点 (2)

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