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

Phase 1

Completed

• Conditions: Malignant Melanoma

• Registration Number: NCT00235482
• Lead Sponsor: Viralytics

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.

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 Timeline

• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Study Start: 2005-11-08
• Primary Completion: 2006-04-21
• Study Completion: 2006-04-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety profile of treatment, characterisation of adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy - clinical response of injected and non-injected tumours

Trial Locations

Locations (1)

Melanoma Unit, Mater Misericordiae Hospital; 🇦🇺 Newcastle, New South Wales, Australia