临床试验/NCT00235482

NCT00235482已完成1 期

Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)

Viralytics2 个研究点分布在 1 个国家目标入组 3 人开始时间: 2005年11月8日最近更新: 2019年6月27日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 3
试验地点: 2
主要终点: Safety profile of treatment, characterisation of adverse events

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

The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

详细描述

Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

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: 21 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•stage IV melanoma (AJCC classification)
•minimum of 2 sc metastases
•failure or refusal of standard chemotherapy
•ECOG score of 0 or 1

排除标准

•metastatic CNS disease
•ocular or mucosal melanoma
•immunodeficiency
•splenectomy

结局指标

主要结局

Safety profile of treatment, characterisation of adverse events

次要结局

Efficacy - clinical response of injected and non-injected tumours

研究者

发起方

Viralytics

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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