Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Viralytics |
---|---|
Information provided by: | Viralytics |
ClinicalTrials.gov Identifier: | NCT00832559 |
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:
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Biological: Coxsackievirus A21 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled |
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 |
Estimated Enrollment: | 9 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate haematological, hepatic and renal function, defined as:
Adequate immunologic function, defined as:
Exclusion Criteria:
Contact: Stephen Ackland, MBBS FRACP | +61 2 4921 1770 | stephen.ackland@newcastle.edu.au |
Australia, New South Wales | |
Calvary Mater Newcastle Hospital | Recruiting |
Newcastle, New South Wales, Australia, 2310 | |
Contact: Stephen Ackland +61 2 4921 1770 stephen.ackland@newcastle.edu.au |
Principal Investigator: | Stephen Ackland | Calvary Mater Newcastle |
Principal Investigator: | Girish Mallesara | Calvary Mater Newcastle |
Responsible Party: | Calvary Mater Newcastle ( Dr Stephen Ackland ) |
Study ID Numbers: | VLA X-06 |
Study First Received: | January 29, 2009 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00832559 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee; Australia: National Health and Medical Research Council |
CAVATAK Coxsackievirus A21 CVA21 Oncolytic virotherapy |
Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell of Head and Neck Coxsackievirus Infections |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Carcinoma |
Neoplasms Neoplasms by Site Head and Neck Neoplasms |