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

Viralytics3 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Melanoma

Interventions

Coxsackievirus A21DRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Melanoma Unit, Mater Misericordiae Hospital

Newcastle, New South Wales, Australia

Outcomes

Primary Outcomes

Safety profile of treatment, characterisation of adverse events

Secondary Outcomes

Efficacy - clinical response of injected and non-injected tumours

Data from ClinicalTrials.gov

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