Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility Criteria
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
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support