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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00003604
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III or IV renal cancer that has been completely resected and is at high risk for recurrence, including at least one of the following: Tumor invades adrenal gland or perinephric tissues but not beyond Gerota's fascia (T3a) OR Tumor extending into renal vein, vena cava (T3b) OR Tumor grossly extends into vena cava above diaphragm (T3c) OR Tumor invades beyond Gerota's fascia (T4) OR Any lymph node involvement totally resected (N1-3) OR Completely resected metastases of all sites No brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 3 times upper limit of normal (ULN) AST or ALT less than 3 times ULN Renal: Creatinine no greater than 1.9 mg/dL Cardiovascular: No prior myocardial infarction within 6 months No LVEF less than 35% No primary cardiac arrhythmias beyond occasional PVCs No angina No uncontrolled congestive heart failure No cerebrovascular accident Pulmonary: No dyspnea at rest or requirement for supplemental oxygen Oxygen saturation greater than 90% for patients with symptomatic lung disease Other: Not pregnant or nursing Negative pregnancy test Fetile patients must use effective contraception Temperatures greater than 100.5 degrees F must have occult infection excluded No psychiatric disorders
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent cyclosporine or methotrexate Endocrine therapy: At least 3 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: At least 2 weeks since prior surgery Other: At least 3 weeks since prior immunosuppressive medications No concurrent immunosuppressive medications
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00003604
Study Brief:
Protocol Section:
NCT00003604