A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)
A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.
3 other identifiers
interventional
9
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2007
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedStudy Start
First participant enrolled
May 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2009
CompletedJuly 1, 2019
June 1, 2019
2.3 years
February 19, 2007
June 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.
Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87
Secondary Outcomes (5)
To determine clinical response of the injected tumour
Days 24, 52, 87
To determine clinical response in non-injected tumours using RECIST criteria
3 months
Time course and quantify CVA21 viremias
3 months
Determine time course to elimination of CVA21
3 months
Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies
3 months
Study Arms (1)
CAVATAK
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- mm 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viralyticslead
Study Sites (1)
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Related Publications (2)
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. doi: 10.1158/1078-0432.ccr-0690-3.
PMID: 14734451BACKGROUNDAu 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. doi: 10.3892/ijo.26.6.1471.
PMID: 15870858BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2007
First Posted
February 21, 2007
Study Start
May 16, 2007
Primary Completion
August 28, 2009
Study Completion
August 28, 2009
Last Updated
July 1, 2019
Record last verified: 2019-06