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

Viralytics

Status and phase: Completed; Phase 1

Conditions: Malignant Melanoma

Treatments: Drug: Coxsackievirus A21

Study type: Interventional

Funder types: Industry

Identifiers

NCT00235482

PSX-X02 (Other Identifier)

V937-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)