Back to results

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

Primary Purpose

Stage IV Melanoma

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

Coxsackievirus A21

About this trial

This is an interventional treatment trial for Stage IV Melanoma focused on measuring coxsackievirus type a21, oncolytic virus, melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Princess Alexandra Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAVATAK

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00438009

First Posted

February 19, 2007

Last Updated

June 26, 2019

Sponsor

Viralytics

1. Study Identification

Unique Protocol Identification Number

NCT00438009

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

May 16, 2007 (Actual)

Primary Completion Date

August 28, 2009 (Actual)

Study Completion Date

August 28, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Viralytics

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Melanoma

Keywords

coxsackievirus type a21, oncolytic virus, melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAVATAK

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Coxsackievirus A21

Other Intervention Name(s)

CAVATAK

Intervention Description

Two doses of drug, separated by 48 hours

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To determine clinical response of the injected tumour

Time Frame

Days 24, 52, 87

Title

To determine clinical response in non-injected tumours using RECIST criteria

Time Frame

3 months

Title

Time course and quantify CVA21 viremias

Time Frame

3 months

Title

Determine time course to elimination of CVA21

Time Frame

3 months

Title

Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Princess Alexandra Hospital

City

Brisbane

State/Province

Queensland

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

14734451

Citation

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.

Results Reference

background

PubMed Identifier

15870858

Citation

Au 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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs