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

June 26, 2019 updated by: Viralytics

A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Princess Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAVATAK
Drug: Coxsackievirus A21
Two doses of drug, separated by 48 hours
Other Names:
  • CAVATAK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viralytics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2007

Primary Completion (Actual)

August 28, 2009

Study Completion (Actual)

August 28, 2009

Study Registration Dates

First Submitted

February 19, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V937-003
  • PAH HREC identifier 2006/49
  • PSX-X03 (Other Identifier: Viralytics Study ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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