Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes in Treating Patients With Metastatic Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of melanoma Metastatic disease Refractory to standard therapy including high-dose interleukin-2 (IL-2) therapy Evaluable disease Patients may enroll at the cell infusion stage provided they have tumor available for biopsy OR expandable SBIL-2-transduced tumor infiltrating lymphocytes available Progressive disease during prior immunization to melanoma antigens or cellular therapy, with or without myeloablation, allowed Symptomatic CNS lesions allowed provided immediate active treatment for symptomatic lesions has been completed PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count greater than 1,000/mm^3 WBC greater than 3,000/mm^3 Lymphocyte count greater than 500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8.0 g/dL No coagulation disorder Hepatic Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome) AST/ALT less than 3 times upper limit of normal Hepatitis B surface antigen negative Hepatitis C virus negative Renal Creatinine no greater than 1.6 mg/dL Cardiovascular No myocardial infarction No cardiac arrhythmias No abnormal stress thallium or comparable test LVEF > 45% and normal stress cardiac test in patients with the following criteria: 50 years old or greater History of EKG abnormalities, symptoms of cardiac ischemia or arrhythmias No major cardiovascular illness Pulmonary No obstructive or restrictive pulmonary disease No major respiratory illness FEV_1 > 60% predicted in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction Immunologic HIV negative No prior severe immediate hypersensitivity reaction No primary or secondary immunodeficiency No active systemic infection No concurrent opportunistic infection No major immune system illness Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study therapy Must sign a durable power of attorney PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior anti-cytotoxic T-lymphocyte antibody-4 antibody (CTLA-4) allowed unless post-MDX010 treatment and colonoscopy with colonic biopsies are normal Chemotherapy Recovered from prior chemotherapy Endocrine therapy No concurrent steroids Radiotherapy Recovered from prior radiotherapy Surgery Not specified Other More than 4 weeks since prior systemic therapy
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- NCI - Center for Cancer Research