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

Sponsor
Viralytics (Industry)
Overall Status
Completed
CT.gov ID
NCT00438009
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
27.4
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Coxsackievirus A21
 Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 28, 2009
Actual Study Completion Date :
Aug 28, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAVATAK

Drug: Coxsackievirus A21
Two doses of drug, separated by 48 hours
Other Names:
  • CAVATAK

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. To determine clinical response of the injected tumour [Days 24, 52, 87]

    2. To determine clinical response in non-injected tumours using RECIST criteria [3 months]

    3. Time course and quantify CVA21 viremias [3 months]

    4. Determine time course to elimination of CVA21 [3 months]

    5. Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Alexandra Hospital Brisbane Queensland Australia

    Sponsors and Collaborators

    • Viralytics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Viralytics
    ClinicalTrials.gov Identifier:
    NCT00438009
    Other Study ID Numbers:
    • V937-003
    • PAH HREC identifier 2006/49
    • PSX-X03
    First Posted:
    Feb 21, 2007
    Last Update Posted:
    Jul 1, 2019
    Last Verified:
    Jun 1, 2019
    Keywords provided by Viralytics
    coxsackievirus type a21
    oncolytic virus
    melanoma
    Additional relevant MeSH terms:
    Coxsackievirus Infections
    Melanoma

    Study Results

    No Results Posted as of Jul 1, 2019