Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Cancer 0 0 0 0
Malignant melanoma

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
Sex
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
NA
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
16/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/08/2009
Sample size
Target
Accrual to date
Final
9
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
Trial website
Trial related presentations / publications
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00438009