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

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ClinicalTrials.gov Identifier: NCT00832559
Recruitment Status : Terminated (Poor recruitment rate.)
First Posted : January 30, 2009
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
Roberta Karpathy, Viralytics

Tracking Information
First Submitted Date  ICMJE January 29, 2009
First Posted Date  ICMJE January 30, 2009
Last Update Posted Date May 27, 2019
Actual Study Start Date  ICMJE January 27, 2009
Actual Primary Completion Date July 28, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2018)
Safety and tolerability of patients to multiple doses of CAVATAK [ Time Frame: 1 year ]
safety and tolerability
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2009)
Safety and tolerability of patients to multiple doses of CAVATAK
Change History Complete list of historical versions of study NCT00832559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients (VLA-X06)
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Biological: CVA21
1, 3 or 6 doses of CAVATAK (10^9 TCID50) at 48 hour intervals.
Other Names:
  • CAVATAK
  • Coxsackievirus A21
Study Arms  ICMJE Experimental: CVA21
CVA21
Intervention: Biological: CVA21
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 22, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2009)
9
Actual Study Completion Date  ICMJE July 28, 2011
Actual Primary Completion Date July 28, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00832559
Other Study ID Numbers  ICMJE VLA-X06
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roberta Karpathy, Viralytics
Study Sponsor  ICMJE Viralytics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Ackland, MBBS FRACP Principal Investigator
PRS Account Viralytics
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP