- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00636558
Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04) (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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New South Wales
-
Kogarah, New South Wales, Australia, 2217
- Cancer Care Centre, St George Hospital
-
-
Queensland
-
Redcliffe, Queensland, Australia, 4020
- Redcliffe Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who are willing and able to provide written informed consent to participate in the study.
- Male or female aged 18 years or older.
- Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma.
- ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy.
- Absence of circulating antibodies to CVA21 (titre < 1:16).
- Patients must have failed or refused standard treatment(s).
Adequate haematological, hepatic and renal function, defined as:
- ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L
- Bilirubin < 20µmol/L, AST < 2.5 times the upper limit of normal
- Calculated creatinine clearance > 30 mL/minute
Adequate immunologic function, defined as:
- Serum IgG > 5g/L
- T cell subsets within normal limits
- Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.
Exclusion Criteria:
- Presence or history of Central Nervous System (CNS) malignancy.
- Patients must not have received chemotherapy within 4 weeks prior to date of consent.
- Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Life expectancy < 6 months.
- Pregnancy or breastfeeding.
- Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone > 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks.
- Positive serology for HIV, hepatitis B or hepatitis C.
- Splenectomy.
- Presence of uncontrolled infection.
- Presence of unstable neurological disease.
- Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study
- Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks
- Known allergy to treatment medication or its excipients
- Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CVA21
IV administration of CVA21 in a dose escalation manner
|
IV infusion, dose escalation of one or two infusions of escalating strength
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
|
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
|
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris Chern, MD, Redcliffe Hospital, Brisbane, Qld., Australia
- Principal Investigator: Winston Liauw, MD, St George Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Enterovirus Infections
- Picornaviridae Infections
- Neuroendocrine Tumors
- Nevi and Melanomas
- Prostatic Neoplasms
- Melanoma
- Coxsackievirus Infections
Other Study ID Numbers
- V937-004
- PSX-X04 (Other Identifier: Viralytics Study ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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