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

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ClinicalTrials.gov Identifier: NCT00636558
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Viralytics

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Breast Cancer Prostate Cancer Drug: CVA21 Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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 (PSX-X04)
Study Start Date : March 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012


Arm Intervention/treatment
Experimental: CVA21
IV administration of CVA21 in a dose escalation manner
Drug: CVA21
IV infusion, dose escalation of one or two infusions of escalating strength
Other Name: CAVATAK



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are willing and able to provide written informed consent to participate in the study.
  2. Male or female aged 18 years or older.
  3. Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma.
  4. ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy.
  5. Absence of circulating antibodies to CVA21 (titre < 1:16).
  6. Patients must have failed or refused standard treatment(s).
  7. 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
  8. Adequate immunologic function, defined as:

    • Serum IgG > 5g/L
    • T cell subsets within normal limits
  9. 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:

  1. Presence or history of Central Nervous System (CNS) malignancy.
  2. Patients must not have received chemotherapy within 4 weeks prior to date of consent.
  3. Performance status > 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  4. Life expectancy < 6 months.
  5. Pregnancy or breastfeeding.
  6. 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.
  7. Positive serology for HIV, hepatitis B or hepatitis C.
  8. Splenectomy.
  9. Presence of uncontrolled infection.
  10. Presence of unstable neurological disease.
  11. 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
  12. Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks
  13. Known allergy to treatment medication or its excipients
  14. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636558


Locations
Australia, New South Wales
Cancer Care Centre, St George Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Redcliffe Hospital
Redcliffe, Queensland, Australia, 4020
Sponsors and Collaborators
Viralytics
Investigators
Principal Investigator: Boris Chern, MD Redcliffe Hospital, Brisbane, Qld., Australia
Principal Investigator: Winston Liauw, MD St George Hospital

Additional Information:
Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT00636558     History of Changes
Other Study ID Numbers: PSX-X04
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Viralytics:
coxsackie virus
melanoma
breast cancer
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Melanoma
Coxsackievirus Infections
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases