High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma

Fecha de inicio: 1 de febrero de 2004

Inclusion Criteria: * Histologically confirmed melanoma * Metastatic disease * Measurable disease * No history of brain metastases * Over 18 * Karnofsky 60-100% * Life expectancy At least 12 weeks * Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome) * Hepatitis B and C negative * Creatinine ≤ 2.0 times ULN * Creatinine clearance ≥ 50 mL/min * Cardiovascular * Ejection fraction ≥ 50% * No evidence of congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No myocardial infarction within the past 6 months * Cardiac stress test negative or of low probability for patients \> 40 years of age OR who have had prior myocardial infarction \> 6 months ago * Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age * Diffusing capacity of lung for carbon monoxide ≥ 60% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative Exclusion Criteria: * No uncontrolled diabetes * No history of autoimmune disease * No active infection * No other concurrent significant illness that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast) * At least 4 weeks since prior immunotherapy and recovered * No other concurrent anticancer biologic agents * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No concurrent chemotherapy * At least 4 weeks since prior steroid therapy * No concurrent corticosteroids * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * At least 4 weeks since prior surgery and recovered * No concurrent immunosuppressive therapy