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:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01864759
Eligibility Criteria:
Inclusion Criteria:
* Malignant melanoma advanced or metastatic.
* Other than 18 years
* Karnofsky index \> 60 %
* Life expectancy \> 3 months
* ALT/AST \<=2.5 times the upper normal limit
* Creatinine clearance \>= 50 ml/min.
* Bilirubin \<25 umol/l
* Alkaline phosphatase \<= 2.5 time upper normal limit
* Normal bone marrow function: Neutrophils \>=1.5 E9/L, platelets \>= 1E11/L, hemoglobin \>= 100 g/l, Normal prothrombin time and thromboplastin time,
* HIV negative
* Measurable disease
* Signed informed consent.
Exclusion Criteria:
* Geographical, social or psychological conditions that may impair the protocol compliance.
* Active infections or other severe medical status.
* History of liver disease.
* Other or concomitant treatments for melanoma or investigational product.
* Previous participation in studies with adenovirus.
* Virus diseases diagnosed two weeks before inclusion.
* Immunosuppressive concomitant treatments
* Concomitant malignant haematological disease.
* Patients having family members with immunodeficient status or disease
* Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01864759
Study Brief:
Protocol Section:
NCT01864759