NCT00636558

Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)

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 (PSX-X04)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Viralytics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma
• Breast Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	CVA21	IV infusion, dose escalation of one or two infusions of escalating strength

Timeline

• Start date: 2008-02-29
• Primary completion: 2012-01-12
• Completion: 2012-01-12
• First posted: 2008-03-14
• Last updated: 2019-07-01

Locations

2 sites across 1 country: Australia