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A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients (VLA-X06) (VLA-X06)

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. Identifier: NCT00832559
Recruitment Status : Terminated (Poor recruitment rate.)
First Posted : January 30, 2009
Last Update Posted : July 19, 2019
Information provided by (Responsible Party):

Brief Summary:

This study is designed to assess the safety and initial indications of efficacy resulting from multiple doses of CAVATAK injected directly into solid tumours of the Head and Neck that have been confirmed to express ICAM-1 and DAF.

CAVATAK (Coxsackievirus A21) is a naturally occurring common cold virus that preclinical research indicates can preferentially infect and kill cancer cells expressing the receptors ICAM-1 and/or DAF. This virus is known to cause self limiting upper respiratory infections and has been used previously to challenge therapies against the common cold. The virus is not generically modified.

The study proposes to administer CAVATAK to three cohorts each of three patients. The first cohort will receive a single dose, the second cohort will receive three doses, and the final cohort will receive six doses. There will a 48 hour interval between repeated doses.

The primary objective of the study is to determine the safety and efficacy of CVA21 given by intratumoural injection in the treatment of recurrent, unresectable squamous cell carcinoma of the head and neck by measuring primary and field tumour status and adverse effects.

Secondary objectives of the study are:

  1. Indirect measurements of efficacy by measuring appropriate biomarkers in serum and tumour biopsy samples for viral replication, induction of apoptosis and anti-tumour immune responses.
  2. To determine the time course of potential primary and secondary viraemia.
  3. To characterise the time course of the anti-CVA21 antibody response after administration of CVA21

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Biological: CVA21 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dosage Escalation, Study of Multiple Doses of CAVATAKTM (CVA21; Coxsackievirus A21) Administered Intratumourally in the Treatment of Squamous Cell Carcinoma of the Head and Neck Bearing ICAM-1 Receptors (VLA-X06)
Actual Study Start Date : January 27, 2009
Actual Primary Completion Date : July 28, 2011
Actual Study Completion Date : July 28, 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CVA21
Biological: CVA21
1, 3 or 6 doses of CAVATAK (10^9 TCID50) at 48 hour intervals.
Other Names:
  • Coxsackievirus A21

Primary Outcome Measures :
  1. Safety and tolerability of patients to multiple doses of CAVATAK [ Time Frame: 1 year ]
    safety and tolerability

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who are willing and able to provide written informed consent to participate in the study.
  2. Patients with histologically confirmed metastatic or recurrent squamous cell carcinoma of the head or neck currently documented as "progressive disease"
  3. Head and neck cancer patients with at least one tumour mass where the tumour mass is accessible for intratumoural injection and can be measured at periodic intervals for tumour size using callipers and/or ultrasound.
  4. All patients to have histologically confirmed squamous cell carcinoma of the head and neck (excluding nasopharyngeal) that had recurred or relapsed after surgery and/or radiotherapy and/or chemotherapy.
  5. The longest diameter of the target injectable tumour being no greater than 6 cm or no less than 1 cm in the longest diameter.
  6. The tumour mass to be intratumourally injected to be easily accessible for injection and amenable to measurement by physical examination and / or radiographically.
  7. Patients to be 18 years or older
  8. Absence of circulating antibodies to CVA21 (titre < 1:16).
  9. Adequate haematological, hepatic and renal function, defined as:

    ANC > 1.5 x 109/L, platelets > 100 x 109/L Bilirubin < 20µmol/L, AST < 2.5 times the upper limit of normal Calculated creatinine clearance > 30 mL/minute

    Adequate immunologic function, defined as:

    Serum IgG > 5g/L T cell subsets within normal limits

  10. Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.

Exclusion Criteria:

  1. Patients receiving radiotherapy to the proposed injected tumour or radiotherapy within the last 3 weeks
  2. Performance status > 1 on the ECOG scale
  3. Life expectancy < 3 months.
  4. Pregnancy or breastfeeding.
  5. Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks.
  6. Positive serology for HIV, Hepatitis B or Hepatitis C.
  7. Splenectomy.
  8. Presence of uncontrolled infection.
  9. 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
  10. Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks
  11. Known allergy to treatment medication or its excipients
  12. Tumours to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumour swelling or erosion into a major vessel in the case of necrosis

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 identifier (NCT number): NCT00832559

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Australia, New South Wales
St Vincents Hospital
Darlinghurst, New South Wales, Australia, 2010
Calvary Mater Newcastle Hospital
Newcastle, New South Wales, Australia, 2310
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Sponsors and Collaborators
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Principal Investigator: Stephen Ackland, MBBS FRACP Principal Investigator
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Responsible Party: Viralytics Identifier: NCT00832559    
Other Study ID Numbers: V937-005
VLA-X06/PSX-X06 ( Other Identifier: Viralytics Study ID )
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Keywords provided by Viralytics:
Coxsackievirus A21
Oncolytic virotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site