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Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02) (PXS-X02)

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ClinicalTrials.gov Identifier: NCT00235482
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Viralytics

October 7, 2005
October 10, 2005
January 12, 2018
November 21, 2005
April 21, 2006   (Final data collection date for primary outcome measure)
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 (PXS-X02)
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
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
Intervention Model: Single Group Assignment
Intervention Model Description:
CAVATAK
Masking: None (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
Same as current
April 21, 2006
April 21, 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00235482
PSX-X02
Not Provided
Not Provided
Not Provided
Viralytics
Viralytics
Not Provided
Not Provided
Viralytics
January 2018

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