Back to resultsIntratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02) (PXS-X02)
Primary Purpose
Malignant Melanoma
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Coxsackievirus A21
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Melanoma
Eligibility Criteria
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
Sites / Locations
- Melanoma Unit, Mater Misericordiae Hospital
Outcomes
Primary Outcome Measures
Safety profile of treatment, characterisation of adverse events
Secondary Outcome Measures
Efficacy - clinical response of injected and non-injected tumours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00235482
Brief Title
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Acronym
PXS-X02
Official Title
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2005 (Actual)
Primary Completion Date
April 21, 2006 (Actual)
Study Completion Date
April 21, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viralytics
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
CAVATAK
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Coxsackievirus A21
Primary Outcome Measure Information:
Title
Safety profile of treatment, characterisation of adverse events
Secondary Outcome Measure Information:
Title
Efficacy - clinical response of injected and non-injected tumours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Melanoma Unit, Mater Misericordiae Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
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