Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers
Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses. [ Time Frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84 ] [ Designated as safety issue: Yes ]
- To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21 [ Time Frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84 ] [ Designated as safety issue: Yes ]
- To characterise the time course of the anti-CVA21 antibody response [ Time Frame: Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
IV administration of CVA21 in a dose escalation manner
IV infusion, dose escalation of one or two infusions of escalating strength
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.
|Australia, New South Wales|
|Cancer Care Centre, St George Hospital|
|Kogarah, Sydney, New South Wales, Australia, 2217|
|Redcliffe, Queensland, Australia, 4020|
|Principal Investigator:||Boris Chern, MD||Redcliffe Hospital, Brisbane, Qld., Australia|
|Principal Investigator:||Winston Liauw, MD||St George Hospital|