MelanomaPhase 1PSX-X04NCT00636558
Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)
A Phase 1 study testing CVA21 in people with Melanoma and Breast Cancer, run by Viralytics at 2 sites in Australia.
Trial summary
Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Breast Cancer, Prostate Cancer
- What is being tested?
- CVA21
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 Feb 2008to 12 Jan 2012
- 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
- Patients who are willing and able to provide written informed consent to participate in the study.
- Male or female aged 18 years or older.
- Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma.
- ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy.
- Absence of circulating antibodies to CVA21 (titre < 1:16).
- Patients must have failed or refused standard treatment(s).
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- Adequate haematological, hepatic and renal function, defined as:
- ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L
- Bilirubin < 20µmol/L, AST < 2.5 times the upper limit of normal
- Calculated creatinine clearance > 30 mL/minute
- Adequate immunologic function, defined as:
- Serum IgG > 5g/L
- T cell subsets within normal limits
- Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.
Who cannot join
- Presence or history of Central Nervous System (CNS) malignancy.
- Patients must not have received chemotherapy within 4 weeks prior to date of consent.
- Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Life expectancy < 6 months.
- Pregnancy or breastfeeding.
- Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks.
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- Positive serology for HIV, hepatitis B or hepatitis C.
- 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
- Known allergy to treatment medication or its 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
2 sites in 1 country.
Australia2 sites
Cancer Care Centre, St George Hospital
Kogarah, New South Wales, 2217
Redcliffe Hospital
Redcliffe, Queensland, 4020
About this study
Official title: A Phase I, Open-Label, Cohort Study of Multiple Doses of Cavatak™ (Coxsackie Virus A21) Given Intravenously to Stage IV Solid Tumour Cancer Patients Bearing ICAM-1 With or Without DAF Expressing Tumours (PSX-X04)
Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study.
Read the detailed description
This is a phase I, multiple dose, dose escalation, open label, cohort study of three intravenous doses of Coxsackie virus A21 in patients with stage IV solid tumours. Prospective patients will attend the study centre for initial screening within 28 days prior to commencement of treatment. They will have the nature of the study and its procedures and risks fully explained. Patients must then sign an informed consent form giving permission for tumour testing before initial screening can be commenced.
Patients whose tumours test positive for ICAM-1 with or without DAF will attend the study centre for a further screening visit within 14 days prior to commencement of treatment. They will sign a full study informed consent form before any further screening procedures are carried out.
Patients who satisfy all inclusion and none of the exclusion criteria will commence the treatment stage, which consists of one or more doses of CVA21 administered by intravenous infusion as per the dosage escalation chart. The first 4 cohorts will be treated as in-patients. The follow up period will consist of 12 weeks, during which time patients will attend the trial centre for up to13 follow up visits to collect safety and efficacy data.
- Conditions
- Melanoma, Breast Cancer, Prostate Cancer
- Being tested
- CVA21
- Keywords
- coxsackie virus, melanoma, breast cancer, prostate cancer
- Medical subject headings
- Melanoma, Breast Neoplasms, Prostatic Neoplasms, Coxsackievirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVA21Drug
Also called CAVATAK
IV infusion, dose escalation of one or two infusions of escalating strength
| Study group | Role | What they receive |
|---|---|---|
| CVA21 | Experimental | IV administration of CVA21 in a dose escalation manner Receives: Drug: CVA21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.
Measured: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Secondary outcomes (2)
To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21
Measured: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
To characterise the time course of the anti-CVA21 antibody response
Measured: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study start29 Feb 2008
- Primary completion12 Jan 2012
- Study completion12 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viralytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Chern, MD, Principal investigator, Redcliffe Hospital, Brisbane, Qld., AustraliaWinston Liauw, MD, Principal investigator, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636558
- Sponsor's protocol ID
- V937-004
- Other IDs
- PSX-X04
- Acronym
- PSX-X04
- Status last verified
- Jun 2019
- First submitted
- 7 Mar 2008
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 Multiple Doses of Cavatak™ (Coxsackie Virus A21) Given Intravenously to Stage IV Solid Tumour Cancer Patients Bearing ICAM-1 With or Without DAF Expressing Tumours (PSX-X04)
- ClinicalTrials.gov ID
- NCT00636558
- Acronym / sponsor ID
- PSX-X04 / V937-004
- Conditions
- Melanoma, Breast Cancer, Prostate Cancer
- Keywords
- coxsackie virus, melanoma, breast cancer, prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ViralyticsIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2008 (actual)
- Primary completion
- 12 Jan 2012 (actual)
- Study completion
- 12 Jan 2012 (actual)
- First posted
- 14 Mar 2008 (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.
Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study.
Detailed description
This is a phase I, multiple dose, dose escalation, open label, cohort study of three intravenous doses of Coxsackie virus A21 in patients with stage IV solid tumours. Prospective patients will attend the study centre for initial screening within 28 days prior to commencement of treatment. They will have the nature of the study and its procedures and risks fully explained. Patients must then sign an informed consent form giving permission for tumour testing before initial screening can be commenced.
Patients whose tumours test positive for ICAM-1 with or without DAF will attend the study centre for a further screening visit within 14 days prior to commencement of treatment. They will sign a full study informed consent form before any further screening procedures are carried out.
Patients who satisfy all inclusion and none of the exclusion criteria will commence the treatment stage, which consists of one or more doses of CVA21 administered by intravenous infusion as per the dosage escalation chart. The first 4 cohorts will be treated as in-patients. The follow up period will consist of 12 weeks, during which time patients will attend the trial centre for up to13 follow up visits to collect safety and efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVA21 | Experimental | Drug: CVA21IV administration of CVA21 in a dose escalation manner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients who are willing and able to provide written informed consent to participate in the study.
- Male or female aged 18 years or older.
- Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma.
- ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy.
- Absence of circulating antibodies to CVA21 (titre < 1:16).
Key exclusion criteria (14 listed)
- Presence or history of Central Nervous System (CNS) malignancy.
- Patients must not have received chemotherapy within 4 weeks prior to date of consent.
- Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Life expectancy < 6 months.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| CVA21Also: CAVATAKIV infusion, dose escalation of one or two infusions of escalating strength | Drug | CVA21 |
Primary outcome
The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.
Time frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
2 secondary outcomes
To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21
Time frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
To characterise the time course of the anti-CVA21 antibody response
Time frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
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.
- Viralytics LimitedLink 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.
Boris Chern, MD principal investigator
Redcliffe Hospital, Brisbane, Qld., Australia
Winston Liauw, MD principal investigator
St. George's Hospital, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVA21 in people with Melanoma and Breast Cancer, run by Viralytics at 2 sites 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 14 inclusion and 14 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 2 sites 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?
The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses. (time frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84). 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 1 Jul 2019.