Skip to main content
OpenTrials
Completed

NCT Number: NCT00235482

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Melanoma Unit, Mater Misericordiae Hospital

Newcastle, New South Wales, 2298, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Coxsackievirus A21

Drug

Primary outcomes

  1. Safety profile of treatment, characterisation of adverse events

Secondary outcomes

  1. Efficacy - clinical response of injected and non-injected tumours

Sponsors and collaborators

Lead sponsor

Viralytics

Industry

Registry information

Acronym: PXS-X02

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 10, 2005
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.