Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000277246
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
15/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I intratumoural trial of Coxsackievirus A21 (CAVATAK) in late stage Head and Neck Cancer patients
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
Secondary ID [1] 838 0
NCT00832559 ClinicalTrials.gov
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 4300 0
Condition category
Condition code
Cancer 4532 4532 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive an intratumoural dose of CAVATAK estimated to be 30% of the injected tumour volume, with a maximum dose of 2mL. All doses will be 10^9 50% Tissue Culture Infectivity Dose (TCID50). The first cohort of patients will receive one dose, the second cohort will receive 3 doses 48 hours apart and the third and final cohort will receive 6 doses 48 hours apart.
Intervention code [1] 4028 0
Treatment: Drugs
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5410 0
Safety: Patients will be monitored by the trial investigators for vital signs, blood chemistry, haematology, Electrocardiogram (ECG) and adverse events.
Timepoint [1] 5410 0
Patients will be monitored by 11 visits over 127 days post treatment
Secondary outcome [1] 9096 0
Size of the injected tumour and non-injected tumours will be measured in each patient to assess the effect of the treatment against the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Timepoint [1] 9096 0
Patients will be monitored by 11 visits over 127 days post treatment

Eligibility
Key inclusion criteria
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.
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 < 20umol/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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within the last 3 weeks
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.
Positive serology for Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
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
Date of first participant enrolment
Anticipated
2/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4480 0
Commercial sector/Industry
Name [1] 4480 0
Viralytics Limited
Country [1] 4480 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Viralytics Limited
Address
1b 55 Grandview Street, Pymble, NSW 2073
Country
Australia
Secondary sponsor category [1] 4039 0
None
Name [1] 4039 0
Address [1] 4039 0
Country [1] 4039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6541 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 6541 0
Ethics committee country [1] 6541 0
Date submitted for ethics approval [1] 6541 0
Approval date [1] 6541 0
Ethics approval number [1] 6541 0
Ethics committee name [2] 269241 0
Southern Health Human Research Ethics Committee A
Ethics committee address [2] 269241 0
Ethics committee country [2] 269241 0
Australia
Date submitted for ethics approval [2] 269241 0
24/03/2011
Approval date [2] 269241 0
Ethics approval number [2] 269241 0
11089A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29266 0
Address 29266 0
Country 29266 0
Phone 29266 0
Fax 29266 0
Email 29266 0
Contact person for public queries
Name 12513 0
Dr Stephen Ackland
Address 12513 0
Department of Medical Oncology
Calvary Mater Hospital Newcastle
Edith Street
Waratah 2310
Country 12513 0
Australia
Phone 12513 0
+61 2 4921 1770
Fax 12513 0
Email 12513 0
[email protected]
Contact person for scientific queries
Name 3441 0
Assoc. Prof. Darren Shafren
Address 3441 0
1b 55 Grandview Street, Pymble NSW 2073
Country 3441 0
Australia
Phone 3441 0
+61 2 4913 8158
Fax 3441 0
Email 3441 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.