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Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma


Phase 1
21 Years
70 Years
Not Enrolling
Both
Malignant Melanoma

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Trial Information

Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile of treatment, characterisation of adverse events

Principal Investigator

Peter Hersey, MBBS, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Conjoint Professor, Newcastle Mater Misericordiae Hopital

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PSX-X-02

NCT ID:

NCT00235482

Start Date:

August 2005

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Coxsackievirus Infections
  • Melanoma

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