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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT00276835
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Documented histologically confirmed malignant melanoma or renal clear cell carcinoma
* Metastatic disease
* At least 1 measurable lesion 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
* 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 or palpable lymph nodes)
* The following are considered non-measurable lesions:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Cystic lesions
* Abdominal masses that are not confirmed and followed by imaging techniques
* No CNS metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
* ECOG performance status \< 2
* Life expectancy ≥ 4 months
* Serum creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min
* Bilirubin normal
* Platelets \> 100,000/mm³
* WBC \> 3,500/mm³
* No evidence of congestive heart failure
* No symptom 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 present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
* Adequate pulmonary reserve
* FEV\_1 \> 75% of predicted
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test
* No known HIV-positive patients
* No evidence of active infection requiring antibiotic therapy
* No contraindication to treatment with pressor agents
* No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study
* No history of another malignancy other than basal cell skin cancer within 5 years
PRIOR CONCURRENT THERAPY:
* Recovered from all toxic effects of prior therapy
* No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment
* No systemic corticosteroids in the 4 weeks prior to treatment
* No previous investigational agent within 4 weeks prior to the start of the study
* No prior interleukin-2 therapy
* No organ allografts allowed
* No concurrent radiotherapy, chemotherapy, or immunotherapy
* No concurrent corticosteroids
* No concurrent chronic medication for asthma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00276835
Study Brief:
Protocol Section:
NCT00276835