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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00832559




Registration number
NCT00832559
Ethics application status
Date submitted
29/01/2009
Date registered
29/01/2009
Date last updated
7/04/2019

Titles & IDs
Public title
A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients (VLA-X06)
Scientific 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)
Secondary ID [1] 0 0
VLA-X06
Universal Trial Number (UTN)
Trial acronym
VLA-X06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CVA21

Experimental: CVA21 - CVA21


Other interventions: CVA21
1, 3 or 6 doses of CAVATAK (10^9 TCID50) at 48 hour intervals.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of patients to multiple doses of CAVATAK - safety and tolerability
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
1. Patients who are willing and able to provide written informed consent to participate
in the study.

2. Patients with histologically confirmed metastatic or recurrent squamous cell carcinoma
of the head or neck currently documented as "progressive disease"

3. 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.

4. 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.

5. The longest diameter of the target injectable tumour being no greater than 6 cm or no
less than 1 cm in the longest diameter.

6. The tumour mass to be intratumourally injected to be easily accessible for injection
and amenable to measurement by physical examination and / or radiographically.

7. Patients to be 18 years or older

8. Absence of circulating antibodies to CVA21 (titre < 1:16).

9. 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

10. 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within
the last 3 weeks

2. Performance status > 1 on the ECOG scale

3. Life expectancy < 3 months.

4. Pregnancy or breastfeeding.

5. 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.

6. Positive serology for HIV, Hepatitis B or Hepatitis C.

7. Splenectomy.

8. Presence of uncontrolled infection.

9. 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

10. Participation in another study requiring administration of an investigational drug or
biological agent within the last 4 weeks

11. Known allergy to treatment medication or its excipients

12. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
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)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincents Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Newcastle
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2310 - Newcastle
Recruitment postcode(s) [3] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Viralytics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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:

1. 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.

2. To determine the time course of potential primary and secondary viraemia.

3. To characterise the time course of the anti-CVA21 antibody response after administration
of CVA21
Trial website
https://clinicaltrials.gov/show/NCT00832559
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Ackland, MBBS FRACP
Address 0 0
Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00832559