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Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235482
First Posted: October 10, 2005
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Viralytics
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235482


Locations
Australia, New South Wales
Melanoma Unit, Mater Misericordiae Hospital
Newcastle, New South Wales, Australia, 2298
Sponsors and Collaborators
Viralytics
  More Information

ClinicalTrials.gov Identifier: NCT00235482     History of Changes
Other Study ID Numbers: PSX-X-02
First Submitted: October 7, 2005
First Posted: October 10, 2005
Last Update Posted: May 10, 2017
Last Verified: May 2017

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