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

NCT ID: NCT00235482

Last Updated: 2019-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-08
• Study Completion Date: 2006-04-21

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Coxsackievirus A21

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Viralytics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Melanoma Unit, Mater Misericordiae Hospital

Newcastle, New South Wales, Australia

Countries

Australia

Other Identifiers

PSX-X02

Identifier Type: OTHER

Identifier Source: secondary_id

V937-002

Identifier Type: -

Identifier Source: org_study_id