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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00832559
Ethics application status
Date submitted
29/01/2009
Date registered
30/01/2009
Date last updated
19/07/2019

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/PSX-X06
Secondary ID [2] 0 0
V937-005
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
Treatment: Other - CVA21

Experimental: CVA21 - CVA21


Treatment: Other: CVA21
1, 3 or 6 doses of CAVATAK (10\^9 TCID50) at 48 hour intervals.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of patients to multiple doses of CAVATAK
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
Sex
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
Not applicable
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2011
Sample size
Target
Accrual to date
Final
4
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/study/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/study/NCT00832559