Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 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 metastatic melanoma Measurable disease Resected or stable brain metastases are allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy At least 3 months Hematopoietic See Immunologic Absolute neutrophil count > 1,000/mm^3 (without support of filgrastim [G-CSF]) Platelet count > 100,000/mm^3 Hemoglobin ≥ 8 g/dL (transfusion allowed) No coagulation disorders Hepatic Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 times upper limit of normal Bilirubin ≤ 2 mg/dL (< 3 mg/dL in patients with Gilbert's syndrome) No hepatitis B or C Renal Creatinine ≤ 1.6 mg/dL Cardiovascular Left ventricular ejection fraction (LVEF) ≥ 45% by cardiac stress test* No active major cardiovascular illness as evidenced by stress thallium or other comparable test No myocardial infarction No cardiac arrhythmias NOTE: *For patients ≥ 50 years of age receiving high-dose interleukin-2 (IL-2) OR patients with a history of electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia, or arrhythmias Pulmonary Forced expiratory volume 1 (FEV_1) ≥ 60% of predicted by pulmonary function test in patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction* No active major respiratory illness No obstructive or restrictive pulmonary disease NOTE: *For patients receiving high-dose IL-2 only Immunologic No active major immunologic illness No active systemic infections No primary or secondary immunodeficiency Fully recovered immune competence after prior chemotherapy or radiotherapy as evidenced by both of the following: Absolute neutrophil count > 1,000/mm^3 No opportunistic infections Human Immunodeficiency virus (HIV) negative Epstein-Barr virus positive Other Not pregnant or nursing Fertile patients must use effective contraception during and for 4 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy At least 6 weeks since prior nitrosourea therapy No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10^6/kg patient weight) have been obtained prior to the administration of chemotherapy Endocrine therapy No concurrent systemic steroid therapy Radiotherapy Not specified Surgery See Disease Characteristics Prior minor surgery within the past 3 weeks allowed if recovered Other Recovered from all prior therapy At least 30 days since prior systemic therapy No other concurrent experimental agents
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- NCI - Surgery Branch
Arms of the Study
Arm 1
Arm 2
Other
Other
TBI 200cGy + TIL +HD IL-2, prior IL-2
TBI 200cGy + TIL +HD IL-2, No prior IL-2
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator. Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.