Intratumoural Administration of Coxsackievirus A21 for the NCT00235482

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00235482
Other study ID #	V937-002
Secondary ID	PSX-X02
Status	Completed
Phase	Phase 1
First received
Last updated
Start date	November 8, 2005
Est. completion date	April 21, 2006

Study information
Verified date	June 2019
Source	Viralytics
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	3
Est. completion date	April 21, 2006
Est. primary completion date	April 21, 2006
Accepts healthy volunteers	No
Gender	All
Age group	21 Years to 70 Years
Eligibility	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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Coxsackievirus A21

Locations
Country	Name	City	State
Australia	Melanoma Unit, Mater Misericordiae Hospital	Newcastle	New South Wales

Sponsors *(1)*
Lead Sponsor	Collaborator
Viralytics

Country where clinical trial is conducted

Australia,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of treatment, characterisation of adverse events
Secondary	Efficacy - clinical response of injected and non-injected tumours

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

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome