Malignant MelanomaPhase 1PXS-X02NCT00235482
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
A Phase 1 study testing Coxsackievirus A21 in people with Malignant Melanoma, run by Viralytics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Coxsackievirus A21
- How many people
- 3 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Nov 2005to 21 Apr 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage IV melanoma (AJCC classification)
- minimum of 2 sc metastases
- failure or refusal of standard chemotherapy
- ECOG score of 0 or 1
- other
Who cannot join
- metastatic CNS disease
- ocular or mucosal melanoma
- immunodeficiency
- splenectomy
- other
Trial locations and contacts
1 site in 1 country.
Australia1 site
Melanoma Unit, Mater Misericordiae Hospital
Newcastle, New South Wales, 2298
About this study
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.
Read the 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.
- Conditions
- Malignant Melanoma
- Being tested
- Coxsackievirus A21
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coxsackievirus A21Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of treatment, characterisation of adverse events
Secondary outcomes (1)
Efficacy - clinical response of injected and non-injected tumours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study start8 Nov 2005
- Primary completion21 Apr 2006
- Study completion21 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CAVATAK
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viralytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235482
- Sponsor's protocol ID
- V937-002
- Other IDs
- PSX-X02
- Acronym
- PXS-X02
- Status last verified
- Jun 2019
- First submitted
- 7 Oct 2005
- Last updated
- 27 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
- ClinicalTrials.gov ID
- NCT00235482
- Acronym / sponsor ID
- PXS-X02 / V937-002
- Conditions
- Malignant Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ViralyticsIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2005 (actual)
- Primary completion
- 21 Apr 2006 (actual)
- Study completion
- 21 Apr 2006 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- CAVATAK
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stage IV melanoma (AJCC classification)
- minimum of 2 sc metastases
- failure or refusal of standard chemotherapy
- ECOG score of 0 or 1
- other
Key exclusion criteria (5 listed)
- metastatic CNS disease
- ocular or mucosal melanoma
- immunodeficiency
- splenectomy
- other
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coxsackievirus A21 | Drug | – |
Primary outcome
Safety profile of treatment, characterisation of adverse events
1 secondary outcome
Efficacy - clinical response of injected and non-injected tumours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Coxsackievirus A21 in people with Malignant Melanoma, run by Viralytics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of treatment, characterisation of adverse events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.