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A Safety Study of Two Intratumoural Doses of Coxsackievirus Type A21 in Melanoma Patients

This study has been completed.
Sponsor:
Information provided by:
Viralytics
ClinicalTrials.gov Identifier:
NCT00438009
First received: February 19, 2007
Last updated: September 22, 2009
Last verified: September 2009
  Purpose

The purpose of the study is to determine the safety and tolerability of two doses of Coxsackievirus A21, administered 48 hours apart into a superficial melanoma tumour.

Injected and non-injected tumours will be observed regarding change in tumour size.

Coxsackievirus A21 (CVA21) is a naturally occurring virus, that is known to cause self limiting upper respiratory infections. CVA21 has been shown in cell culture to infect and kill human melanoma cancer cell lines. This property of CVA21 is due to the specific receptors CVA21 uses in order to attach to, and infect a cell. The 2 receptors CVA21 uses to infect a cell are Intracellular Adhesion Molecule 1 (ICAM-1) and Decay Accelerating Factor. Both of these surface proteins are expressed on melanoma cell lines as well as human melanoma tumours. Animal models of human melanoma tumours have demonstrated that CVA21 injection either intratumour or intravenous causes infection in the tumours, resulting in reduction of tumour size and growth.


Condition Intervention Phase
Stage IV 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: A Phase I, Open Label, Cohort Study of Two Doses of Cavatak (Coxsackievirus Type A21) Given Intratumourally in Stage IV Melanoma Patients.

Resource links provided by NLM:


Further study details as provided by Viralytics:

Primary Outcome Measures:
  • Safety and tolerability of two doses of Coxsackievirus A21 administered intratumourally. [ Time Frame: Days 1, 3, 6, 8, 10, 13, 17, 24, 38, 52, 87 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine clinical response of the injected tumour [ Time Frame: Days 24, 52, 87 ] [ Designated as safety issue: No ]
  • To determine clinical response in non-injected tumours using RECIST criteria [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Time course and quantify CVA21 viremias [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Determine time course to elimination of CVA21 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Determine time course, frequency as well as quantify the development of anti-CVA21 antibodies [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Coxsackievirus A21
    Two doses of drug, separated by 48 hours
    Other Name: CAVATAK
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 18 years of age.
  • One subcutaneous melanoma metastatic deposit, 2.0 to 5.0 cm in diameter, accessible to 3mm punch biopsy and injection, may be tumour infiltrated lymph node.
  • Melanoma stage IV.
  • 3mm punch biopsy of the selected tumour must be expressing ICAM-1 and DAF.
  • Absence of circulating antibodies to CVA21 (titre < 1:16)
  • Patients must have adequate hematological, renal and hepatic function
  • Failed or refused standard treatment (s)
  • Patients are able and willing to provide signed/informed consent to participate in the study.
  • Fertile males and females must agree to the use of adequate form of contraception, eg. Condoms for males
  • Negative pregnancy test is required for female patients of child bearing potential.

Exclusion Criteria:

  • Mucosal or ocular tumour
  • Presence of CNS tumour
  • Radiotherapy to the injection tumour site.
  • Prior local radiotherapy without subsequent nodule progression
  • Chemotherapy within 4 weeks of screening visit.
  • ECOG score greater than 1.
  • Life expectancy less than 3 months.
  • Pregnancy or breast feeding.
  • Primary or secondary immunodeficiency, including immuno-suppressive doses of corticosteroids (prednisolone greater than 7.5 mg/day, or other immuno-suppressive drugs such as cyclosporine, azothioprine, interferons, within the 4 weeks prior to screening visit.
  • Positive serology for HIV, Hepatitis B virus or Hepatitis C virus
  • Full dose anticoagulation, or a history of bleeding diathesis, or history of difficult to control bleeding in the month before screening visit.
  • Previous splenectomy.
  • Presence of uncontrolled infection.
  • Presence of unstable neurological disease
  • Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study
  • Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks prior to screening visit.
  • Known allergy to treatment medication or excipients
  • Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
  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: NCT00438009

Locations
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Sponsors and Collaborators
Viralytics
Investigators
Principal Investigator: Mark Smithers, MBBS FRACS FRCS Princess Alexandra Hospital, Brisbane, Australia
Principal Investigator: Damien Thomson, MBBS FRACP Director of Oncology. Princess Alexandra Hospital. Brisbane, Australia
  More Information

Additional Information:
Publications:
Responsible Party: Stephen Goodall, Chief Operating Officer
ClinicalTrials.gov Identifier: NCT00438009     History of Changes
Other Study ID Numbers: PSX-X-03, PAH HREC identifier 2006/49
Study First Received: February 19, 2007
Last Updated: September 22, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Viralytics:
coxsackievirus type a21
oncolytic virus
melanoma

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

ClinicalTrials.gov processed this record on November 19, 2014