Working… Menu

A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00438009
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : July 1, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Stage IV Melanoma Drug: Coxsackievirus A21 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.
Actual Study Start Date : May 16, 2007
Actual Primary Completion Date : August 28, 2009
Actual Study Completion Date : August 28, 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: CAVATAK Drug: Coxsackievirus A21
Two doses of drug, separated by 48 hours
Other Name: CAVATAK

Primary Outcome Measures :
  1. Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally. [ Time Frame: Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87 ]

Secondary Outcome Measures :
  1. To determine clinical response of the injected tumour [ Time Frame: Days 24, 52, 87 ]
  2. To determine clinical response in non-injected tumours using RECIST criteria [ Time Frame: 3 months ]
  3. Time course and quantify CVA21 viremias [ Time Frame: 3 months ]
  4. Determine time course to elimination of CVA21 [ Time Frame: 3 months ]
  5. Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00438009

Layout table for location information
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Sponsors and Collaborators
Layout table for additonal information
Responsible Party: Viralytics Identifier: NCT00438009    
Other Study ID Numbers: V937-003
PAH HREC identifier 2006/49
PSX-X03 ( Other Identifier: Viralytics Study ID )
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Keywords provided by Viralytics:
coxsackievirus type a21
oncolytic virus
Additional relevant MeSH terms:
Layout table for MeSH terms
Coxsackievirus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases