Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers - Full Text View

Sponsor:	Viralytics
Information provided by (Responsible Party):	Viralytics
ClinicalTrials.gov Identifier:	NCT00636558

Purpose

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.

Condition	Intervention	Phase
Melanoma Breast Cancer Prostate Cancer	Drug: CVA21	Phase I

Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Melanoma Prostate Cancer

U.S. FDA Resources

Further study details as provided by Viralytics:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	9
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 IV administration of CVA21 in a dose escalation manner	Drug: CVA21 IV infusion, dose escalation of one or two infusions of escalating strength

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636558

Contacts

Contact: Roberta Karpathy

+61 418 865 707

Roberta.Karpathy@newcastle.edu.au

Locations

Australia, New South Wales
Cancer Care Centre, St George Hospital	Recruiting
Kogarah, Sydney, New South Wales, Australia, 2217
Contact: Antoinette Fontella (02) 9113 1920 Antoinette.Fontela@sesiahs.health.nsw.gov.au
Principal Investigator: Winston Liauw, MD
Australia, Queensland
Redcliffe Hospital	Recruiting
Redcliffe, Queensland, Australia, 4020
Contact: Maree Duroux +61(7)38837190 maree_duroux@health.qld.gov.au
Contact: Megan Ratcliffe +61(7)38837530 megan_ratcliffe@health.qld.gov.au
Principal Investigator: Boris Chern, MD

Sponsors and Collaborators

Viralytics

Investigators

Principal Investigator:	Boris Chern, MD	Redcliffe Hospital, Brisbane, Qld., Australia
Principal Investigator:	Winston Liauw, MD	St George Hospital

More Information

No publications provided

Responsible Party:	Viralytics
ClinicalTrials.gov Identifier:	NCT00636558 History of Changes
Other Study ID Numbers:	PSX-X04
Study First Received:	March 7, 2008
Last Updated:	October 19, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Viralytics:

coxsackie virus
melanoma
breast cancer
prostate cancer

Additional relevant MeSH terms:

Breast Neoplasms
Coxsackievirus Infections
Melanoma
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Virus Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012