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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.
 
ClinicalTrials.gov Identifier: NCT00438009
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Viralytics

Tracking Information
First Submitted Date  ICMJE February 19, 2007
First Posted Date  ICMJE February 21, 2007
Last Update Posted Date July 1, 2019
Actual Study Start Date  ICMJE May 16, 2007
Actual Primary Completion Date August 28, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • To determine clinical response of the injected tumour [ Time Frame: Days 24, 52, 87 ]
  • To determine clinical response in non-injected tumours using RECIST criteria [ Time Frame: 3 months ]
  • Time course and quantify CVA21 viremias [ Time Frame: 3 months ]
  • Determine time course to elimination of CVA21 [ Time Frame: 3 months ]
  • Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
  • To determine clinical response of the injected tumour
  • To determine clinical response in non-injected tumours using RECIST criteria
  • Time course and quantify CVA21 viremias
  • Determine time course to elimination of CVA21
  • Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients (PSX-X03)
Official Title  ICMJE A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage IV Melanoma
Intervention  ICMJE Drug: Coxsackievirus A21
Two doses of drug, separated by 48 hours
Other Name: CAVATAK
Study Arms  ICMJE Experimental: CAVATAK
Intervention: Drug: Coxsackievirus A21
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2007)
9
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 28, 2009
Actual Primary Completion Date August 28, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00438009
Other Study ID Numbers  ICMJE V937-003
PAH HREC identifier 2006/49
PSX-X03 ( Other Identifier: Viralytics Study ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Viralytics
Study Sponsor  ICMJE Viralytics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Viralytics
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP