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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
N/A
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
8/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/04/2006
Sample size
Target
Accrual to date
Final
3
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00235482