Official Title
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Phase
Phase 1Lead Sponsor
ViralyticsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Malignant MelanomaIntervention/Treatment
coxsackievirus a21 ...Study Participants
3The 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.
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.
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