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Eligibility: 13eeb3e968ee81e92b354355772a84c2 [RDF]

Label 13eeb3e968ee81e92b354355772a84c2
Slug 13eeb3e968ee81e92b354355772a84c2
Criteria DISEASE CHARACTERISTICS: - Histologically confirmed surgically incurable metastatic malignant melanoma - Measurable disease - No active brain metastases or edema - No leptomeningeal disease - No ocular melanoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT less than 3 times the upper limit of normal unless due to liver metastases Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 75 mL/min Cardiovascular: - No congestive heart failure - No symptoms of coronary artery disease - No serious cardiac arrhythmias - No prior myocardial infarction on EKG - Normal cardiac stress test required for the following: - Over 50 years of age - Abnormal EKG - Prior history of cardiac disease Pulmonary: - No symptomatic pulmonary disease - FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant infection - HIV negative - No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No organ allografts - No significant disease other than malignancy - No seizure disorder PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior interleukin-2 therapy for metastatic disease - At least 4 weeks since prior vaccine therapy - At least 4 weeks since prior adjuvant immunotherapy Chemotherapy: - No prior chemotherapy for disease Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - No prior radiation therapy to measurable disease site unless disease is clearly progressive - At least 4 weeks since prior radiation therapy for local control or palliation and recovered Surgery: - Recovered from prior surgery Other: - No prior systemic therapy for metastatic disease - At least 3 months since definitive therapy for brain metastases
Maximum age N/A
Healthy volunteers No
Study pop
Minimum age 18 Years
Gender Both
Sampling method
Provenances http://clinicaltrials.gov/show/NCT00003027?displayxml=true
Similars None
Interlinks None