Cyclophosphamide and Fludarabine Followed By an Autologous Lymphocyte Infusion and Interleukin-2 in Treating Patients With Refractory or Recurrent 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: Diagnosis of melanoma Metastatic disease Measurable disease HLA-A2 negative disease Disease did not respond to OR recurred after completion of prior high-dose interleukin-2 (IL-2) Eligible to receive high-dose IL-2 No tumor reactive cells available for cell transfer therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 8.0 g/dL No coagulation disorders Hepatic ALT and AST < 3 times upper limit of normal Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL if due to Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antigen negative Renal Creatinine ≤ 2.0 mg/dL No renal failure requiring dialysis due to toxic effects of prior IL-2 administration Cardiovascular No myocardial infarction No cardiac arrhythmias No other major cardiovascular illness as evidenced by a positive stress thallium or comparable test Normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram) AND LVEF ≥ 45% (for patients ≥ 50 years of age or who have a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias) Pulmonary No obstructive or restrictive pulmonary disease No other major respiratory illness FEV_1 ≥ 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction) Immunologic HIV negative Epstein-Barr virus positive No active systemic infection No autoimmune disease (e.g., autoimmune colitis or Crohn's disease) No immunodeficiency due to prior chemotherapy or radiotherapy Recovered immune competence after prior chemotherapy or radiotherapy as evidenced by normal lymphocyte count and WBC and an absence of opportunistic infection No other major immune system disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after completion of study treatment No other toxic effects during prior IL-2 administration that would preclude redosing with IL-2, including the following: Mental status changes that would require intubation Bowel perforation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 4 weeks since prior systemic therapy Chemotherapy At least 6 weeks since prior nitrosoureas At least 4 weeks since prior systemic therapy Endocrine therapy No concurrent systemic steroid therapy Radiotherapy Not specified Surgery Not specified
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- NCI - Surgery Branch