Stage IV MelanomaPhase 1NCT00438009
A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)
A Phase 1 study testing Coxsackievirus A21 in people with Stage IV Melanoma, run by Viralytics at 1 site in Australia.
Trial summary
The purpose of the study is to determine the safety and tolerability of two doses of Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour. Injected and non-injected tumours will be observed regarding change in tumour size. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma
- What is being tested?
- Coxsackievirus A21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteAustralia
- Study dates
- 16 May 2007to 28 Aug 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age.
- One subcutaneous melanoma metastatic deposit, 2.0 to 5.0 cm in diameter, accessible to 3mm punch biopsy and injection, may be tumour infiltrated lymph node.
- Melanoma stage IV.
- 3mm punch biopsy of the selected tumour must be expressing ICAM-1 and DAF.
- Absence of circulating antibodies to CVA21 (titre < 1:16)
- Patients must have adequate hematological, renal and hepatic function
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- Failed or refused standard treatment (s)
- Patients are able and willing to provide signed/informed consent to participate in the study.
- Fertile males and females must agree to the use of adequate form of contraception, eg. Condoms for males
- Negative pregnancy test is required for female patients of child bearing potential.
Who cannot join
- Mucosal or ocular tumour
- Presence of CNS tumour
- Radiotherapy to the injection tumour site.
- Prior local radiotherapy without subsequent nodule progression
- Chemotherapy within 4 weeks of screening visit.
- ECOG score greater than 1.
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- Life expectancy less than 3 months.
- Pregnancy or breast feeding.
- Primary or secondary immunodeficiency, including immuno-suppressive doses of corticosteroids (prednisolone greater than 7.5 mg/day, or other immuno-suppressive drugs such as cyclosporine, azothioprine, interferons, within the 4 weeks prior to screening visit.
- Positive serology for HIV, Hepatitis B virus or Hepatitis C virus
- Full dose anticoagulation, or a history of bleeding diathesis, or history of difficult to control bleeding in the month before screening visit.
- Previous splenectomy.
- Presence of uncontrolled infection.
- Presence of unstable neurological disease
- Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study
- Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks prior to screening visit.
- Known allergy to treatment medication or excipients
- Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.
The purpose of the study is to determine the safety and tolerability of two doses of Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.
Injected and non-injected tumours will be observed regarding change in tumour size.
Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and kill human melanoma cancer cell lines. This property of CVA21 is due to the specific receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor. Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection either intratumour or intravenous causes infection in the tumours, resulting in reduction of tumour size and growth.
- Conditions
- Stage IV Melanoma
- Being tested
- Coxsackievirus A21
- Keywords
- coxsackievirus type a21, oncolytic virus, melanoma
- 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
Also called CAVATAK
Two doses of drug, separated by 48 hours
| Study group | Role | What they receive |
|---|---|---|
| CAVATAK | Experimental | Not described Receives: Drug: Coxsackievirus A21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.
Measured: Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87
Secondary outcomes (5)
To determine clinical response of the injected tumour
Measured: Days 24, 52, 87
To determine clinical response in non-injected tumours using RECIST criteria
Measured: 3 months
Time course and quantify CVA21 viremias
Measured: 3 months
Determine time course to elimination of CVA21
Measured: 3 months
Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study start16 May 2007
- Primary completion28 Aug 2009
- Study completion28 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stage IV 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viralytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438009
- Sponsor's protocol ID
- V937-003
- Other IDs
- PAH HREC identifier 2006/49, PSX-X03
- Status last verified
- Jun 2019
- First submitted
- 19 Feb 2007
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shafren DR, Au GG, Nguyen T, Newcombe NG, Haley ES, Beagley L, Johansson ES, Hersey P, Barry RD. Systemic therapy of malignant human melanoma tumors by a common cold-producing enterovirus, coxsackievirus a21. Clin Cancer Res. 2004 Jan 1;10(1 Pt 1):53-60. doi: 10.1158/1078-0432.ccr-0690-3.
PubMed 14734451Au GG, Lindberg AM, Barry RD, Shafren DR. Oncolysis of vascular malignant human melanoma tumors by Coxsackievirus A21. Int J Oncol. 2005 Jun;26(6):1471-6. doi: 10.3892/ijo.26.6.1471.
PubMed 15870858
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.
- ClinicalTrials.gov ID
- NCT00438009
- Acronym / sponsor ID
- V937-003
- Conditions
- Stage IV Melanoma
- Keywords
- coxsackievirus type a21, oncolytic virus, melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ViralyticsIndustry (pharma, biotech, devices)
- Study start
- 16 May 2007 (actual)
- Primary completion
- 28 Aug 2009 (actual)
- Study completion
- 28 Aug 2009 (actual)
- First posted
- 21 Feb 2007 (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 the study is to determine the safety and tolerability of two doses of Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.
Injected and non-injected tumours will be observed regarding change in tumour size.
Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and kill human melanoma cancer cell lines. This property of CVA21 is due to the specific receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor. Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection either intratumour or intravenous causes infection in the tumours, resulting in reduction of tumour size and growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAVATAK | Experimental | Drug: Coxsackievirus A21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Greater than 18 years of age.
- One subcutaneous melanoma metastatic deposit, 2.0 to 5.0 cm in diameter, accessible to 3mm punch biopsy and injection, may be tumour infiltrated lymph node.
- Melanoma stage IV.
- 3mm punch biopsy of the selected tumour must be expressing ICAM-1 and DAF.
- Absence of circulating antibodies to CVA21 (titre < 1:16)
Key exclusion criteria (18 listed)
- Mucosal or ocular tumour
- Presence of CNS tumour
- Radiotherapy to the injection tumour site.
- Prior local radiotherapy without subsequent nodule progression
- Chemotherapy within 4 weeks of screening visit.
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 A21Also: CAVATAKTwo doses of drug, separated by 48 hours | Drug | CAVATAK |
Primary outcome
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.
Time frame: Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87
5 secondary outcomes
To determine clinical response of the injected tumour
Time frame: Days 24, 52, 87
To determine clinical response in non-injected tumours using RECIST criteria
Time frame: 3 months
Time course and quantify CVA21 viremias
Time frame: 3 months
Determine time course to elimination of CVA21
Time frame: 3 months
Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies
Time frame: 3 months
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 1 Jul 2019.
- Background: PubMed 14734451Shafren DR, Au GG, Nguyen T, Newcombe NG, Haley ES, Beagley L, Johansson ES, Hersey P, Barry RD. Systemic therapy of malignant human melanoma tumors by a common cold-producing enterovirus, coxsackievirus a21. Clin Cancer Res. 2004 Jan 1;10(1 Pt 1):53-60. doi: 10.1158/1078-0432.ccr-0690-3.
- Background: PubMed 15870858Au GG, Lindberg AM, Barry RD, Shafren DR. Oncolysis of vascular malignant human melanoma tumors by Coxsackievirus A21. Int J Oncol. 2005 Jun;26(6):1471-6. doi: 10.3892/ijo.26.6.1471.
- Sponsor WebsiteLink provided by the sponsor.
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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 Stage IV 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 10 inclusion and 18 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 1 Jul 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 and tolerability of two doses of Coxsackievirus A21 administered intratumourally. (time frame: Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00438009, which also lists 2 linked publications.
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 1 Jul 2019.