Head and Neck CancerPhase 1VLA-X06NCT00832559
A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients (VLA-X06)
A Phase 1 study testing CVA21 in people with Head and Neck Cancer, run by Viralytics at 3 sites in Australia.
Trial summary
This study is designed to assess the safety and initial indications of efficacy resulting from multiple doses of CAVATAK injected directly into solid tumours of the Head and Neck that have been confirmed to express ICAM-1 and DAF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- CVA21
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesAustralia
- Study dates
- 27 Jan 2009to 28 Jul 2011
- 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.
- Patients with histologically confirmed metastatic or recurrent squamous cell carcinoma of the head or neck currently documented as "progressive disease"
- Head and neck cancer patients with at least one tumour mass where the tumour mass is accessible for intratumoural injection and can be measured at periodic intervals for tumour size using callipers and/or ultrasound.
- All patients to have histologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal) that had recurred or relapsed after surgery and/or radiotherapy and/or chemotherapy.
- The longest diameter of the target injectable tumour being no greater than 6 cm or no less than 1 cm in the longest diameter.
- The tumour mass to be intratumourally injected to be easily accessible for injection and amenable to measurement by physical examination and / or radiographically.
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- Patients to be 18 years or older
- Absence of circulating antibodies to CVA21 (titre < 1:16).
- Adequate haematological, hepatic and renal function, defined as:
- ANC > 1.5 x 109/L, platelets > 100 x 109/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
- Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within the last 3 weeks
- Performance status > 1 on the ECOG scale
- Life expectancy < 3 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.
- Positive serology for HIV, Hepatitis B or Hepatitis C.
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- Splenectomy.
- Presence of uncontrolled infection.
- 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
- Tumours to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumour swelling or erosion into a major vessel in the case of necrosis
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
St Vincents Hospital
Darlinghurst, New South Wales, 2010
Calvary Mater Newcastle Hospital
Newcastle, New South Wales, 2310
About this study
Official title: A Phase I, Open-label, Dosage Escalation, Study of Multiple Doses of CAVATAKTM (CVA21; Coxsackievirus A21) Administered Intratumourally in the Treatment of Squamous Cell Carcinoma of the Head and Neck Bearing ICAM-1 Receptors (VLA-X06)
This study is designed to assess the safety and initial indications of efficacy resulting from multiple doses of CAVATAK injected directly into solid tumours of the Head and Neck that have been confirmed to express ICAM-1 and DAF.
CAVATAK (Coxsackievirus A21) is a naturally occurring common cold virus that preclinical research indicates can preferentially infect and kill cancer cells expressing the receptors ICAM-1 and/or DAF. This virus is known to cause self limiting upper respiratory infections and has been used previously to challenge therapies against the common cold. The virus is not generically modified.
Read more
The study proposes to administer CAVATAK to three cohorts each of three patients. The first cohort will receive a single dose, the second cohort will receive three doses, and the final cohort will receive six doses. There will a 48 hour interval between repeated doses.
The primary objective of the study is to determine the safety and efficacy of CVA21 given by intratumoural injection in the treatment of recurrent, unresectable squamous cell carcinoma of the head and neck by measuring primary and field tumour status and adverse effects.
Secondary objectives of the study are:
- Indirect measurements of efficacy by measuring appropriate biomarkers in serum and tumour biopsy samples for viral replication, induction of apoptosis and anti-tumour immune responses.
- To determine the time course of potential primary and secondary viraemia.
- To characterise the time course of the anti-CVA21 antibody response after administration of CVA21
- Conditions
- Head and Neck Cancer
- Being tested
- CVA21
- Keywords
- CAVATAK, Coxsackievirus A21, CVA21, Oncolytic virotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVA21Biological
Also called CAVATAK, Coxsackievirus A21
1, 3 or 6 doses of CAVATAK (10^9 TCID50) at 48 hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| CVA21 | Experimental | CVA21 Receives: Biological: CVA21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of patients to multiple doses of CAVATAK
safety and tolerability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study start27 Jan 2009
- Primary completion28 Jul 2011
- Study completion28 Jul 2011
Why it stopped: Poor recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viralytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Ackland, MBBS FRACP, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832559
- Sponsor's protocol ID
- V937-005
- Other IDs
- VLA-X06/PSX-X06
- Acronym
- VLA-X06
- Status last verified
- Jul 2019
- First submitted
- 29 Jan 2009
- Last updated
- 19 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dosage Escalation, Study of Multiple Doses of CAVATAKTM (CVA21; Coxsackievirus A21) Administered Intratumourally in the Treatment of Squamous Cell Carcinoma of the Head and Neck Bearing ICAM-1 Receptors (VLA-X06)
- ClinicalTrials.gov ID
- NCT00832559
- Acronym / sponsor ID
- VLA-X06 / V937-005
- Conditions
- Head and Neck Cancer
- Keywords
- CAVATAK, Coxsackievirus A21, CVA21, Oncolytic virotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment rate.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- ViralyticsIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2009 (actual)
- Primary completion
- 28 Jul 2011 (actual)
- Study completion
- 28 Jul 2011 (actual)
- First posted
- 30 Jan 2009 (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.
This study is designed to assess the safety and initial indications of efficacy resulting from multiple doses of CAVATAK injected directly into solid tumours of the Head and Neck that have been confirmed to express ICAM-1 and DAF.
CAVATAK (Coxsackievirus A21) is a naturally occurring common cold virus that preclinical research indicates can preferentially infect and kill cancer cells expressing the receptors ICAM-1 and/or DAF. This virus is known to cause self limiting upper respiratory infections and has been used previously to challenge therapies against the common cold. The virus is not generically modified.
The study proposes to administer CAVATAK to three cohorts each of three patients. The first cohort will receive a single dose, the second cohort will receive three doses, and the final cohort will receive six doses. There will a 48 hour interval between repeated doses.
The primary objective of the study is to determine the safety and efficacy of CVA21 given by intratumoural injection in the treatment of recurrent, unresectable squamous cell carcinoma of the head and neck by measuring primary and field tumour status and adverse effects.
Secondary objectives of the study are:
- Indirect measurements of efficacy by measuring appropriate biomarkers in serum and tumour biopsy samples for viral replication, induction of apoptosis and anti-tumour immune responses.
- To determine the time course of potential primary and secondary viraemia.
- To characterise the time course of the anti-CVA21 antibody response after administration of CVA21
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 | Biological: CVA21CVA21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who are willing and able to provide written informed consent to participate in the study.
- Patients with histologically confirmed metastatic or recurrent squamous cell carcinoma of the head or neck currently documented as "progressive disease"
- Head and neck cancer patients with at least one tumour mass where the tumour mass is accessible for intratumoural injection and can be measured at periodic intervals for tumour size using callipers and/or ultrasound.
- All patients to have histologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal) that had recurred or relapsed after surgery and/or radiotherapy and/or chemotherapy.
- The longest diameter of the target injectable tumour being no greater than 6 cm or no less than 1 cm in the longest diameter.
Key exclusion criteria (12 listed)
- Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within the last 3 weeks
- Performance status > 1 on the ECOG scale
- Life expectancy < 3 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.
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: CAVATAK, Coxsackievirus A211, 3 or 6 doses of CAVATAK (10^9 TCID50) at 48 hour intervals. | Biological | CVA21 |
Primary outcome
Safety and tolerability of patients to multiple doses of CAVATAK
Time frame: 1 year
safety and tolerability
Results and safety
The study was stopped early (reason given: Poor recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Stephen Ackland, MBBS FRACP principal investigator
Principal Investigator
3 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 Head and Neck Cancer, run by Viralytics at 3 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 13 inclusion and 12 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: stopped early, as of the sponsor's last update on 19 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 3 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 was stopped early (reason given: Poor recruitment rate.). Results are not available in the source record.
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 patients to multiple doses of CAVATAK (time frame: 1 year). 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 19 Jul 2019.