A Phase I, Open-Label, Cohort Study of Multiple Doses of Cavatak™ (Coxsackie Virus A21) Given Intravenously to Stage IV Solid Tumour Cancer Patients Bearing ICAM-1 With or Without DAF Expressing Tumours
This is a phase I, multiple dose, dose escalation, open label, cohort study of three
intravenous doses of Coxsackie virus A21 in patients with stage IV solid tumours.
Prospective patients will attend the study centre for initial screening within 28 days prior
to commencement of treatment. They will have the nature of the study and its procedures and
risks fully explained. Patients must then sign an informed consent form giving permission
for tumour testing before initial screening can be commenced.
Patients whose tumours test positive for ICAM-1 with or without DAF will attend the study
centre for a further screening visit within 14 days prior to commencement of treatment.
They will sign a full study informed consent form before any further screening procedures
are carried out.
Patients who satisfy all inclusion and none of the exclusion criteria will commence the
treatment stage, which consists of one or more doses of CVA21 administered by intravenous
infusion as per the dosage escalation chart. The first 4 cohorts will be treated as
in-patients. The follow up period will consist of 12 weeks, during which time patients will
attend the trial centre for up to13 follow up visits to collect safety and efficacy data.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Boris Chern, MD
Redcliffe Hospital, Brisbane, Qld., Australia
Australia: Department of Health and Ageing Therapeutic Goods Administration