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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00235482
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: Coxsackievirus A21 Phase 1

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Intervention Model Description: CAVATAK
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Actual Study Start Date : November 21, 2005
Primary Completion Date : April 21, 2006
Study Completion Date : April 21, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Safety profile of treatment, characterisation of adverse events

Secondary Outcome Measures :
  1. Efficacy - clinical response of injected and non-injected tumours

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235482

Australia, New South Wales
Melanoma Unit, Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298
Sponsors and Collaborators
More Information

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT00235482     History of Changes
Other Study ID Numbers: PSX-X02
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Coxsackievirus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases