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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00636558




Registration number
NCT00636558
Ethics application status
Date submitted
7/03/2008
Date registered
14/03/2008
Date last updated
1/07/2019

Titles & IDs
Public title
Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)
Scientific 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)
Secondary ID [1] 0 0
PSX-X04
Secondary ID [2] 0 0
V937-004
Universal Trial Number (UTN)
Trial acronym
PSX-X04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Breast Cancer 0 0
Prostate Cancer 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CVA21

Experimental: CVA21 - IV administration of CVA21 in a dose escalation manner


Treatment: Drugs: CVA21
IV infusion, dose escalation of one or two infusions of escalating strength
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.
Timepoint [1] 0 0
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Secondary outcome [1] 0 0
To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21
Timepoint [1] 0 0
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Secondary outcome [2] 0 0
To characterise the time course of the anti-CVA21 antibody response
Timepoint [2] 0 0
Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/01/2012
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Cancer Care Centre, St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4020 - Redcliffe

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Viralytics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00636558
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boris Chern, MD
Address 0 0
Redcliffe Hospital, Brisbane, Qld., Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00636558