Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma
Recurrent Melanoma, Stage IV Melanoma
About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Diagnosis of metastatic melanoma No tumor reactive cells available for cell transfer therapy Measurable disease Previously treated with interleukin-2 (IL-2) and meets 1 of the following criteria: No response (progressive disease) Recurrent disease HLA*0201 positive ECOG performance status 0 or 1 Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 8.0 g/dL ALT and AST < 3 times upper limit of normal Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL if Gilbert's disease is present) Creatinine ≤ 2.0 mg/dL Life expectancy ≥ 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 4 months after receiving the preparative regimen No active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, or obstructive or restrictive pulmonary disease No autoimmune disease (e.g., autoimmune colitis or Crohn's disease) or primary immunodeficiency disease No HIV positivity No hepatitis B or C virus positivity No Epstein-Barr virus negativity Eligible to receive high-dose IL-2, as evidenced by the following: Patients ≥ 50 years of age must have a normal cardiac stress test (e.g., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) AND LVEF ≥ 45% Patients with a history of EKG abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test AND LVEF ≥ 45% Patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction must have a normal pulmonary function test, as evidenced by FEV 1 ≥ 60% of predicted At least 4 weeks since prior systemic therapy At least 6 weeks since prior nitrosourea therapy No concurrent systemic steroid therapy Recovered immune competence after prior chemotherapy or radiotherapy No prior gp100:209-217 or MART-1:27-35 peptide vaccine
Sites / Locations
- National Cancer Institute Surgery Branch
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients undergo apheresis and in-vitro depletion of T-regulatory cells. Patients then receive a nonmyeloablative, lymphocyte-depleting preparative regimen comprising cyclophosphamide IV over 1 hour on days -8 and -7 and fludarabine IV over 15-30 minutes on days -6 to -2 followed by autologous T-regulatory-depleted lymphocytes IV over 20-30 minutes on day 0. Patients receive vaccination with gp100:209-217 (210M) and MART-1:27-35 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on days 0-3, 20-23, 41-44, and 62-65. Patients also receive filgrastim (G-CSF) SC beginning on day 1 and continuing until blood counts recover.
Patients receive treatment as in arm I. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 0-4, beginning after the lymphocyte infusion. IL-2 treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.