Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma - Full Text View

Sponsored by:	Viralytics
Information provided by:	Viralytics
ClinicalTrials.gov Identifier:	NCT00235482

Purpose

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.

Condition	Intervention	Phase
Malignant Melanoma	Drug: Coxsackievirus A21	Phase I

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

Further study details as provided by Viralytics:

Primary Outcome Measures:

Safety profile of treatment, characterisation of adverse events

Secondary Outcome Measures:

Efficacy - clinical response of injected and non-injected tumours

Estimated Enrollment:	3
Study Start Date:	August 2005

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.

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235482

Locations

Australia, New South Wales
Melanoma Unit, Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298

Sponsors and Collaborators

Viralytics

Investigators

Principal Investigator:

Peter Hersey, MBBS, DPhil

Conjoint Professor, Newcastle Mater Misericordiae Hopital

More Information

Study ID Numbers:	PSX-X-02
Study First Received:	October 7, 2005
Last Updated:	September 12, 2007
ClinicalTrials.gov Identifier:	NCT00235482
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Virus Diseases
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Picornaviridae Infections

Nevus
Enterovirus Infections
Coxsackievirus Infections
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009