A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma

Date de début de l'étude : 1 août 2004

DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Metastatic disease * Measurable or evaluable disease * Disease progression during or after prior interleukin-2 (IL-2) OR ineligible to receive high-dose IL-2\* OR has disease burden for which IL-2 is not indicated\* NOTE: \*If patient did not receive prior IL-2, must have progressed after prior standard first-line therapy (e.g., metastasectomy for single lesions or dacarbazine) * HLA-A\*0201-positive disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3\* * Absolute lymphocyte count ≥ 200/mm\^3\* * Platelet count \> 100,000/mm\^3 * No proliferative hematologic disease NOTE: \*For 2 consecutive readings performed on 2 different days Hepatic * AST and ALT \< 3 times upper limit of normal (ULN) * PT/PTT ≤ 1.5 times ULN * Hepatitis B negative * Positive hepatitis B serology indicative of prior immunization (i.e., positive for antibody against hepatitis B surface antigen AND negative for antibody against hepatitis B core antigen) allowed * Hepatitis C negative Renal * Creatinine ≤ 1.4 mg/dL Cardiovascular * Ejection fraction \> 45% by MUGA for patients ≥ 50 years of age OR with a history of cardiac disease * No resting blood pressure \> 140/90 mm Hg with standard antihypertensive therapy Pulmonary * DLCO/VA and FEV\_1 \> 50% of predicted on pulmonary function test for smokers OR for patients with clinical evidence of compromised pulmonary function * No history of severe asthma Immunologic * HIV negative * No history of autoimmune disease * No splenomegaly Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other medical or psychiatric disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 4 weeks since prior cytokines * No prior allogeneic hematopoietic stem cell transplantation * No concurrent growth factors * No concurrent monoclonal antibodies * No other concurrent immunotherapy * No other concurrent cytokines * No other concurrent biologic agents Chemotherapy * See Disease Characteristics * No prior intensive myeloablative chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 2 weeks since prior systemic corticosteroids for more than 72 hours in duration * No concurrent systemic steroids Radiotherapy * Not specified Surgery * See Disease Characteristics * No prior splenectomy * No prior solid organ transplantation Other * More than 4 weeks since prior cytotoxic therapy * No other concurrent cytotoxic therapy * No concurrent chronic anticoagulation therapy (e.g., high-dose warfarin, heparin, or aspirin) * Concurrent low-dose warfarin (1-2 mg) allowed * No concurrent chronic medication for asthma * No concurrent immunosuppressive therapy