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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT00278369
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Documented histologically confirmed metastatic renal cell carcinoma
* Clear cell histology
* Disease must be measurable as defined by lesions that can be accurately measured in at least one dimension with longest diameter \> 20 mm using conventional techniques or \> 10 mm with spiral CT scan
* Must have at least one measurable lesion
* If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
* Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes)
* The following are considered nonmeasurable lesions:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Cystic lesions
* Abdominal masses not confirmed and followed by imaging techniques
* No CNS metastases
PATIENT CHARACTERISTICS:
* ECOG performance status \< 2
* Life expectancy of at least 4 months
* Serum creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min
* Total bilirubin normal
* Platelets \> 100,000/mm³
* WBC \> 3,500/mm³
* No evidence of congestive heart failure
* No symptoms of coronary artery disease
* No serious cardiac arrhythmias
* A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms are present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
* Adequate pulmonary reserve
* Pulmonary function tests (PFTs) must be performed within 42 days of IL-2 treatment
* FEV\_1 \> 2.0 liters of \> 75% predicted for height and age
* Patients unable to perform PFTs will be excluded
* Women who are pregnant or lactating are not eligible
* Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
* Negative pregnancy test
* No known HIV-positive patients
* No evidence of active infection requiring antibiotic therapy
* Must not have a contraindication to treatment with pressor agents
* Must not have any significant medical disease that, in the opinion of the investigator, may interfere with completion of the study
* No history of another malignancy within the past 5 years other than basal cell skin cancer
PRIOR CONCURRENT THERAPY:
* Recovered from all toxic effects of prior therapy
* Must not currently receive chronic medication for asthma
* No prior interleukin-2 (IL-2) therapy
* No prior organ allografts
* No systemic corticosteroids in the 4 weeks prior to treatment
* No concurrent systemic steroids
* No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of study treatment
* No concurrent radiotherapy, chemotherapy, or other immunotherapy
* No previous investigational agent within 4 weeks prior to the start of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00278369
Study Brief:
Protocol Section:
NCT00278369