Intratumoural Administration of Coxsackievirus A21 for th... | NCT00235482

Studies
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)

NCT00235482

Sponsor

Viralytics

Status

Completed

Last Update Posted

Jun 27, 2019Actual

Enrollment

3Actual

Phase

Phase 1

Conditions

Malignant Melanoma

Interventions

Coxsackievirus A21

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PSX-X02	Other Identifier	Viralytics Study ID

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2005Actual

Primary Completion Date

Apr 21, 2006Actual

Completion Date

Apr 21, 2006Actual

First Submitted Date

Oct 7, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2019

Last Update Posted Date

Jun 27, 2019Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Name	Type	Description	Arm Group Labels	Other Names
Coxsackievirus A21	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety profile of treatment, characterisation of adverse events

Secondary Outcomes

Measure	Description	Time Frame
Efficacy - clinical response of injected and non-injected tumours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Melanoma Unit, Mater Misericordiae Hospital		Newcastle	New South Wales	2298	Australia

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided