Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
Viralytics
ClinicalTrials.gov Identifier:
NCT00235482
First received: October 7, 2005
Last updated: September 12, 2007
Last verified: September 2007
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Coxsackievirus Infections
Melanoma
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 26, 2014