Malignant Melanoma
Conditions
Brief summary
The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.
Detailed description
Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.
Interventions
Sponsors
Viralytics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CAVATAK
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* stage IV melanoma (AJCC classification) * minimum of 2 sc metastases * failure or refusal of standard chemotherapy * ECOG score of 0 or 1 * other
Exclusion criteria
* metastatic CNS disease * ocular or mucosal melanoma * immunodeficiency * splenectomy * other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile of treatment, characterisation of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy - clinical response of injected and non-injected tumours | — |
Countries
Australia
Outcome results
None listed