Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000636651
Ethics application status
Approved
Date submitted
10/10/2005
Date registered
13/10/2005
Date last updated
13/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase 1 Study of Coxsackievirus A21 for the treatment of melanoma
Scientific title
Intratumoural administration of coxsackievirus A21 for the control of malignant melanoma.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 764 0
Condition category
Condition code
Cancer 840 840 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single intratumoural injection of coxsackievirus A21.
Intervention code [1] 708 0
Treatment: Drugs
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1078 0
Safety profile of treatment
Timepoint [1] 1078 0
Assessed three times weekly for 2 weeks, then weekly for 2 weeks.
Primary outcome [2] 1079 0
Characterisation of adverse events
Timepoint [2] 1079 0
Assessed three times weekly for 2 weeks, then weekly for 2 weeks.
Secondary outcome [1] 1998 0
Clinical response of injected and non-injected tumours.
Timepoint [1] 1998 0
Assessed weekly for 4 weeks.

Eligibility
Key inclusion criteria
Stage IV melanoma (AJCC)- minimum of 2 SC metastases- failure or refusal of standard chemotherapy- ECOG score of 0 or 1- other.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic CNS disease- occular or mucosal melanoma- immunodeficiency- splenectomy- other.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 928 0
Commercial sector/Industry
Name [1] 928 0
Viralytics Ltd.
Country [1] 928 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Viralytics Ltd.
Address
8/33 Ryde Rd., Pymble, NSW 2073
Country
Australia
Secondary sponsor category [1] 787 0
None
Name [1] 787 0
N/A
Address [1] 787 0
Country [1] 787 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35315 0
Address 35315 0
Country 35315 0
Phone 35315 0
Fax 35315 0
Email 35315 0
Contact person for public queries
Name 9897 0
Dr. Phillip Altman
Address 9897 0
Melanoma Unit
Mater Misericordiae Hospital
Newcastle NSW 2298
Country 9897 0
Australia
Phone 9897 0
+61 2 49850100
Fax 9897 0
Email 9897 0
Peter.Hersey@newcastle.edu.au
Contact person for scientific queries
Name 825 0
Phillip Altman
Address 825 0
8/33 Ryde Rd., Pymble, NSW 2073
Country 825 0
Australia
Phone 825 0
+61(2)94993200
Fax 825 0
+61(2)94993300
Email 825 0
pmaltman@bigpond.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.