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

Phase 1
18 Years
Not Enrolling
Stage IV Melanoma

Thank you

Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87

Safety Issue:


Principal Investigator

Mark Smithers, MBBS FRACS FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Alexandra Hospital, Brisbane, Australia


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

February 2007

Completion Date:

September 2009

Related Keywords:

  • Stage IV Melanoma
  • coxsackievirus type a21
  • oncolytic virus
  • melanoma
  • Coxsackievirus Infections
  • Melanoma