临床试验/NCT00514072

NCT00514072Unknown2 期

A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation

Kael-GemVax Co., Ltd.2 个研究点分布在 1 个国家目标入组 54 人开始时间: 2007年3月最近更新: 2012年8月9日

适应症

试验速览

阶段: 2 期
发起方: Kael-GemVax Co., Ltd.
入组人数: 54
试验地点: 2
主要终点: Time to PSA progression

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 tumor cells may help the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with a placebo in treating patients with stage D0 prostate cancer.

详细描述

OBJECTIVES:

Primary

To determine whether ONY-P1 vaccine can increase the time to PSA-defined progression in patients with androgen-dependent stage D0 prostate cancer.

Secondary

To evaluate all toxicities related to ONY-P1 vaccine.
To compare the immunologic response in patients treated with ONY-P1 vaccine vs placebo.
To evaluate PSA kinetics (doubling time/velocity) of treatment.
To evaluate time to testosterone recovery following limited androgen ablation.

研究设计

研究类型: Interventional
分配方式: Randomized
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Male
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

Time to PSA progression

次要结局

Toxicity
Immunologic response as assessed by ELISPOT assay
PSA kinetics (doubling time/velocity) of treatment
Time to testosterone recovery

研究者

发起方

Kael-GemVax Co., Ltd.

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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