A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients
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:
- 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.
- To determine the time course of potential primary and secondary viraemia.
- To characterise the time course of the anti-CVA21 antibody response after administration of CVA21
|Study Design:||Intervention Model: Single Group Assignment
Masking: 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|
- Safety and tolerability of patients to multiple doses of CAVATAK [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Biological: Coxsackievirus A21
- Coxsackievirus A21
|Australia, New South Wales|
|St Vincents Hospital|
|Darlinghurst, New South Wales, Australia, 2010|
|Calvary Mater Newcastle Hospital|
|Newcastle, New South Wales, Australia, 2310|
|Monash Medical Centre|
|Clayton, Victoria, Australia, 3168|
|Principal Investigator:||Stephen Ackland||Calvary Mater Newcastle|
|Principal Investigator:||David N Dalley, MBBS, FRACP||St Vincents Hospital|
|Principal Investigator:||Jason Lickliter||Monash Medical Centre, Clayton|