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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00438009




Registration number
NCT00438009
Ethics application status
Date submitted
19/02/2007
Date registered
21/02/2007
Date last updated
1/07/2019

Titles & IDs
Public title
A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)
Scientific title
A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.
Secondary ID [1] 0 0
PAH HREC identifier 2006/49
Secondary ID [2] 0 0
V937-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage IV Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Coxsackievirus A21

Experimental: CAVATAK -


Treatment: Drugs: Coxsackievirus A21
Two doses of drug, separated by 48 hours

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.
Timepoint [1] 0 0
Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87
Secondary outcome [1] 0 0
To determine clinical response of the injected tumour
Timepoint [1] 0 0
Days 24, 52, 87
Secondary outcome [2] 0 0
To determine clinical response in non-injected tumours using RECIST criteria
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Time course and quantify CVA21 viremias
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Determine time course to elimination of CVA21
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies
Timepoint [5] 0 0
3 months

Eligibility
Key inclusion criteria
- Greater than 18 years of age.

- One subcutaneous melanoma metastatic deposit, 2.0 to 5.0 cm in diameter, accessible to
3mm punch biopsy and injection, may be tumour infiltrated lymph node.

- Melanoma stage IV.

- 3mm punch biopsy of the selected tumour must be expressing ICAM-1 and DAF.

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

- Patients must have adequate hematological, renal and hepatic function

- Failed or refused standard treatment (s)

- Patients are able and willing to provide signed/informed consent to participate in the
study.

- Fertile males and females must agree to the use of adequate form of contraception, eg.
Condoms for males

- Negative pregnancy test is required for 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
- Mucosal or ocular tumour

- Presence of CNS tumour

- Radiotherapy to the injection tumour site.

- Prior local radiotherapy without subsequent nodule progression

- Chemotherapy within 4 weeks of screening visit.

- ECOG score greater than 1.

- Life expectancy less than 3 months.

- Pregnancy or breast feeding.

- Primary or secondary immunodeficiency, including immuno-suppressive doses of
corticosteroids (prednisolone greater than 7.5 mg/day, or other immuno-suppressive
drugs such as cyclosporine, azothioprine, interferons, within the 4 weeks prior to
screening visit.

- Positive serology for HIV, Hepatitis B virus or Hepatitis C virus

- Full dose anticoagulation, or a history of bleeding diathesis, or history of difficult
to control bleeding in the month before screening visit.

- Previous 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 prior to screening visit.

- Known allergy to treatment medication or excipients

- Any other medical or psychological condition that would preclude participation in the
study or compromise ability to give informed consent.

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
Completed
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)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine the safety and tolerability of two doses of
Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.

Injected and non-injected tumours will be observed regarding change in tumour size.

Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self
limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and
kill human melanoma cancer cell lines. This property of CVA21 is due to the specific
receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to
infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor.
Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma
tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection
either intratumour or intravenous causes infection in the tumours, resulting in reduction of
tumour size and growth.
Trial website
https://clinicaltrials.gov/show/NCT00438009
Trial related presentations / publications
Shafren DR, Au GG, Nguyen T, Newcombe NG, Haley ES, Beagley L, Johansson ES, Hersey P, Barry RD. Systemic therapy of malignant human melanoma tumors by a common cold-producing enterovirus, coxsackievirus a21. Clin Cancer Res. 2004 Jan 1;10(1 Pt 1):53-60.
Au GG, Lindberg AM, Barry RD, Shafren DR. Oncolysis of vascular malignant human melanoma tumors by Coxsackievirus A21. Int J Oncol. 2005 Jun;26(6):1471-6.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
Other publications