Phase 1 Study of Coxsackievirus A21 for the treatment of melanoma

Phase 1

Completed

• Conditions: Malignant Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12605000636651
• Lead Sponsor: Viralytics Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Stage IV melanoma (AJCC)- minimum of 2 SC metastases- failure or refusal of standard chemotherapy- ECOG score of 0 or 1- other.

Exclusion Criteria

Metastatic CNS disease- occular or mucosal melanoma- immunodeficiency- splenectomy- other.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety profile of treatment[Assessed three times weekly for 2 weeks, then weekly for 2 weeks.];Characterisation of adverse events[Assessed three times weekly for 2 weeks, then weekly for 2 weeks.]

Secondary Outcome Measures

Name	Time	Method
Clinical response of injected and non-injected tumours.[Assessed weekly for 4 weeks.]