Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00636558
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00636558
Study Brief:
Protocol Section:
NCT00636558