Back to results

Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04) (PSX-X04)

Primary Purpose

Melanoma, Breast Cancer, Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

CVA21

About this trial

This is an interventional treatment trial for Melanoma focused on measuring coxsackie virus, melanoma, breast cancer, prostate cancer

Eligibility Criteria

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

Inclusion Criteria:

Patients who are willing and able to provide written informed consent to participate in the study.
Male or female aged 18 years or older.
Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma.
ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy.
Absence of circulating antibodies to CVA21 (titre < 1:16).
Patients must have failed or refused standard treatment(s).
Adequate haematological, hepatic and renal function, defined as:
- ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L
- Bilirubin < 20µmol/L, AST < 2.5 times the upper limit of normal
- Calculated creatinine clearance > 30 mL/minute
Adequate immunologic function, defined as:
- Serum IgG > 5g/L
- T cell subsets within normal limits
Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.

Exclusion Criteria:

Presence or history of Central Nervous System (CNS) malignancy.
Patients must not have received chemotherapy within 4 weeks prior to date of consent.
Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Life expectancy < 6 months.
Pregnancy or breastfeeding.
Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks.
Positive serology for HIV, hepatitis B or hepatitis C.
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
Known allergy to treatment medication or its excipients
Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Sites / Locations

Cancer Care Centre, St George Hospital
Redcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CVA21

Arm Description

IV administration of CVA21 in a dose escalation manner

Outcomes

Primary Outcome Measures

The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.

Secondary Outcome Measures

To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21

To characterise the time course of the anti-CVA21 antibody response

Full Information

NCT ID

NCT00636558

First Posted

March 7, 2008

Last Updated

June 26, 2019

Sponsor

Viralytics

1. Study Identification

Unique Protocol Identification Number

NCT00636558

Brief Title

Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)

Acronym

PSX-X04

Official Title

A Phase I, Open-Label, Cohort Study of Multiple Doses of Cavatak™ (Coxsackie Virus A21) Given Intravenously to Stage IV Solid Tumour Cancer Patients Bearing ICAM-1 With or Without DAF Expressing Tumours (PSX-X04)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

February 29, 2008 (Actual)

Primary Completion Date

January 12, 2012 (Actual)

Study Completion Date

January 12, 2012 (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

Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study.

Detailed Description

This is a phase I, multiple dose, dose escalation, open label, cohort study of three intravenous doses of Coxsackie virus A21 in patients with stage IV solid tumours. Prospective patients will attend the study centre for initial screening within 28 days prior to commencement of treatment. They will have the nature of the study and its procedures and risks fully explained. Patients must then sign an informed consent form giving permission for tumour testing before initial screening can be commenced. Patients whose tumours test positive for ICAM-1 with or without DAF will attend the study centre for a further screening visit within 14 days prior to commencement of treatment. They will sign a full study informed consent form before any further screening procedures are carried out. Patients who satisfy all inclusion and none of the exclusion criteria will commence the treatment stage, which consists of one or more doses of CVA21 administered by intravenous infusion as per the dosage escalation chart. The first 4 cohorts will be treated as in-patients. The follow up period will consist of 12 weeks, during which time patients will attend the trial centre for up to13 follow up visits to collect safety and efficacy data.

6. Conditions and Keywords

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

Melanoma, Breast Cancer, Prostate Cancer

Keywords

coxsackie virus, melanoma, breast cancer, prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CVA21

Arm Type

Experimental

Arm Description

IV administration of CVA21 in a dose escalation manner

Intervention Type

Drug

Intervention Name(s)

CVA21

Other Intervention Name(s)

CAVATAK

Intervention Description

IV infusion, dose escalation of one or two infusions of escalating strength

Primary Outcome Measure Information:

Title

The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.

Time Frame

Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

Secondary Outcome Measure Information:

Title

To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21

Time Frame

Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

Title

To characterise the time course of the anti-CVA21 antibody response

Time Frame

Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who are willing and able to provide written informed consent to participate in the study. Male or female aged 18 years or older. Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma. ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy. Absence of circulating antibodies to CVA21 (titre < 1:16). Patients must have failed or refused standard treatment(s). Adequate haematological, hepatic and renal function, defined as: ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L Bilirubin < 20µmol/L, AST < 2.5 times the upper limit of normal Calculated creatinine clearance > 30 mL/minute Adequate immunologic function, defined as: Serum IgG > 5g/L T cell subsets within normal limits Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential. Exclusion Criteria: Presence or history of Central Nervous System (CNS) malignancy. Patients must not have received chemotherapy within 4 weeks prior to date of consent. Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale. Life expectancy < 6 months. Pregnancy or breastfeeding. Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks. Positive serology for HIV, hepatitis B or hepatitis C. 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 Known allergy to treatment medication or its excipients Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris Chern, MD

Organizational Affiliation

Redcliffe Hospital, Brisbane, Qld., Australia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Winston Liauw, MD

Organizational Affiliation

St George Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Care Centre, St George Hospital

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Redcliffe Hospital

City

Redcliffe

State/Province

Queensland

ZIP/Postal Code

4020

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)

We'll reach out to this number within 24 hrs