A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)
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|ClinicalTrials.gov Identifier: NCT00438009|
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : July 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Melanoma||Drug: Coxsackievirus A21||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.|
|Actual Study Start Date :||May 16, 2007|
|Actual Primary Completion Date :||August 28, 2009|
|Actual Study Completion Date :||August 28, 2009|
Drug: Coxsackievirus A21
Two doses of drug, separated by 48 hours
Other Name: CAVATAK
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438009
|Princess Alexandra Hospital|
|Brisbane, Queensland, Australia|