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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00291369
Eligibility Criteria:
Inclusion Criteria:
* Progressive histologically proven metastatic renal cell carcinoma.
* Patient with only 1 metastatic site and Karnofsky = 80% or more than 1 metastatic site and Karnofsky \>= 80%.
* Age \>= 18
* No wide-field radiation therapy for 6 weeks at least.
* No active brain metastasis.
* Blood values within limits of normal (hematocrit \> 30% and leukocyte count \>= 4x109/l and platelet count \>= 120x109/l).
* Creatinine \< 150 µmol/l and bilirubin \<= normal.
* Female patients of childbearing potential: effective method of contraception is necessary.
* Written, voluntary, informed consent.
Exclusion Criteria:
* Previous treatment with cytokines.
* Only one metastatic organ and Karnofsky = 90% or 100% (inclusion in good prognosis group).
* More than one metastatic organ (at least one metastasis to the liver) and \<12 months between initial diagnosis and diagnosis of metastasis.
* Active brain metastases.
* Patient with concurrent grade III/IV heart disorder (congestive heart failure, coronary artery disease, uncontrolled hypertension, severe arrhythmia, etc) and/or stroke volume \< 50%.
* Severe pulmonary, hepatic, or renal disease potentially aggravated by treatment.
* Severe concurrent infection necessitating antibiotics
* Patient with known HIV or AIDS-related disease, or presence of HB antigen or known chronic hepatitis.
* Previous allograft.
* Patient under corticosteroid treatment.
* Previous or concurrent primary malignancies at other sites (except from baso-cellular skin cancer or cervical cancer in situ)
* Pregnant or lactating woman.
* Follow-up difficult because of geography or personal circumstances.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00291369
Study Brief:
Protocol Section:
NCT00291369