Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
Viralytics
ClinicalTrials.gov Identifier:
NCT00235482
First received: October 7, 2005
Last updated: September 12, 2007
Last verified: September 2007

October 7, 2005
September 12, 2007
August 2005
Not Provided
Safety profile of treatment, characterisation of adverse events
Same as current
Complete list of historical versions of study NCT00235482 on ClinicalTrials.gov Archive Site
Efficacy - clinical response of injected and non-injected tumours
Same as current
Not Provided
Not Provided
 
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: Coxsackievirus A21
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
Not Provided
Not Provided

Inclusion Criteria:

  • stage IV melanoma (AJCC classification)
  • minimum of 2 sc metastases
  • failure or refusal of standard chemotherapy
  • ECOG score of 0 or 1
  • other

Exclusion Criteria:

  • metastatic CNS disease
  • ocular or mucosal melanoma
  • immunodeficiency
  • splenectomy
  • other
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00235482
PSX-X-02
Not Provided
Not Provided
Viralytics
Not Provided
Principal Investigator: Peter Hersey, MBBS, DPhil Conjoint Professor, Newcastle Mater Misericordiae Hopital
Viralytics
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP