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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

Phase 1
18 Years
Not Enrolling
Melanoma, Breast Cancer, Prostate Cancer

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Trial Information

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

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.

Inclusion Criteria:

1. Patients who are willing and able to provide written informed consent to participate
in the study.

2. Male or female aged 18 years or older.

3. Stage IV solid tumour disease with the primary tumour being any one of the following
types - breast, prostate or melanoma.

4. ICAM-1 with or without DAF-expressing tumour. Patients without archival material for
testing must agree to a new tumour biopsy.

5. Absence of circulating antibodies to CVA21 (titre < 1:16).

6. Patients must have failed or refused standard treatment(s).

7. 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

8. Adequate immunologic function, defined as:

- Serum IgG > 5g/L

- T cell subsets within normal limits

9. 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:

1. Presence or history of Central Nervous System (CNS) malignancy.

2. Patients must not have received chemotherapy within 4 weeks prior to date of consent.

3. Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

4. Life expectancy < 6 months.

5. Pregnancy or breastfeeding.

6. 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.

7. Positive serology for HIV, hepatitis B or hepatitis C.

8. Splenectomy.

9. Presence of uncontrolled infection.

10. Presence of unstable neurological disease.

11. 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

12. Participation in another study requiring administration of an investigational drug or
biological agent within the last 4 weeks

13. Known allergy to treatment medication or its excipients

14. Any other medical or psychological condition that would preclude participation in the
study or compromise ability to give informed consent.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Boris Chern, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Redcliffe Hospital, Brisbane, Qld., Australia


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

March 2008

Completion Date:

June 2012

Related Keywords:

  • Melanoma
  • Breast Cancer
  • Prostate Cancer
  • coxsackie virus
  • melanoma
  • breast cancer
  • prostate cancer
  • Breast Neoplasms
  • Coxsackievirus Infections
  • Melanoma
  • Prostatic Neoplasms