A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)
Status:
Completed
Trial end date:
2009-08-28
Target enrollment:
Participant gender:
Summary
The purpose of the study is to determine the safety and tolerability of two doses of
Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.
Injected and non-injected tumours will be observed regarding change in tumour size.
Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self
limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and
kill human melanoma cancer cell lines. This property of CVA21 is due to the specific
receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to
infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor.
Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma
tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection
either intratumour or intravenous causes infection in the tumours, resulting in reduction of
tumour size and growth.