A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.|
- 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 ] [ Designated as safety issue: Yes ]
- To determine clinical response of the injected tumour [ Time Frame: Days 24, 52, 87 ] [ Designated as safety issue: No ]
- To determine clinical response in non-injected tumours using RECIST criteria [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Time course and quantify CVA21 viremias [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Determine time course to elimination of CVA21 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Drug: Coxsackievirus A21
|Princess Alexandra Hospital|
|Brisbane, Queensland, Australia|
|Principal Investigator:||Mark Smithers, MBBS FRACS FRCS||Princess Alexandra Hospital, Brisbane, Australia|
|Principal Investigator:||Damien Thomson, MBBS FRACP||Director of Oncology. Princess Alexandra Hospital. Brisbane, Australia|