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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Two doses of drug, separated by 48 hours
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.
Time frame: Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87
To determine clinical response of the injected tumour
Time frame: Days 24, 52, 87
To determine clinical response in non-injected tumours using RECIST criteria
Time frame: 3 months
Time course and quantify CVA21 viremias
Time frame: 3 months
Determine time course to elimination of CVA21
Time frame: 3 months
Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies
Time frame: 3 months
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