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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00235482




Registration number
NCT00235482
Ethics application status
Date submitted
7/10/2005
Date registered
10/10/2005
Date last updated
27/06/2019

Titles & IDs
Public title
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Scientific title
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Secondary ID [1] 0 0
PSX-X02
Secondary ID [2] 0 0
V937-002
Universal Trial Number (UTN)
Trial acronym
PXS-X02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Coxsackievirus A21

Treatment: Drugs: Coxsackievirus A21


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety profile of treatment, characterisation of adverse events
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Efficacy - clinical response of injected and non-injected tumours
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
21 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- metastatic CNS disease

- ocular or mucosal melanoma

- immunodeficiency

- splenectomy

- other

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Melanoma Unit, Mater Misericordiae Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2298 - Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Viralytics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00235482
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications