Clinical Trial: A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.

Brief 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.


Detailed Summary:
Sponsor: Viralytics

Current Primary Outcome: 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 ]

Original Primary Outcome: Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • To determine clinical response of the injected tumour
  • To determine clinical response in non-injected tumours using RECIST criteria
  • Time course and quantify CVA21 viremias
  • Determine time course to elimination of CVA21
  • Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies


Information By: Viralytics

Dates:
Date Received: February 19, 2007
Date Started: February 2007
Date Completion:
Last Updated: May 9, 2017
Last Verified: May 2017