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Protocol Number: 00-C-0216 
Patients 16 years of age and older with stage II or stage III melanoma (i.e., at least one positive lymph node), or whose tumor has been surgically removed may be eligible for this study. Patients must be clinically free of disease at the time they enter the study. (Patients who had positive lymph node(s) or surgery to remove their metastasis have a high likelihood of disease relapse.) Candidates will be screened with a physical examination, blood and urine tests, and an electrocardiogram. Patients must have the tissue type HLA-A*0201; this will be determined by a blood test. Participants will have scans and X-rays to evaluate that they are disease free. They will then be randomly assigned to one of three treatment schedules: one group will receive the vaccine once a week for 10 weeks; a second group will receive it four times-once every 3 weeks; and the third group will receive it four times a week every 3 weeks for four times. The vaccine is given as an injection (shot) in the thigh. Treatment will continue for 10 to 12 months, and physical examinations and blood tests will be done frequently to assess side effects. Scans and x-rays will be repeated at least every 6 months to evaluate for tumor recurrence. About 40 cc (8 teaspoons) of blood will be drawn every 12 weeks. Patients will undergo leukapheresis before starting treatment and again after the fourth vaccine in patients receiving weekly injections, and after the second and fourth vaccine in those receiving injections every 3 weeks. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The lymphocytes are then removed, and the rest of the blood-red cells, platelets and plasma-is returned to the body through a second needle in the other arm. Leukapheresis is done to evaluate how the vaccine affects the action of lymphocytes. A biopsy of normal skin and tumor or lymph node may be done to examine the effects of the vaccine on the immune cells in the tumor. Depending on the type and location of tissue, biopsies may be performed with a needle (needle biopsy), with a small sharp cookie-cutter instrument (punch biopsy), or with a small knife (excisional biopsy). Patients whose cancer returns during or after peptide treatment may be given a treatment called interleukin-2 (IL-2), to boost the immune reaction to the tumor. IL-2 is infused through a vein over 15 minutes, and is given every 8 hours for 4 days every 3 to 4 weeks. Patients who receive IL-2 will remain in the hospital for 5-7 days for this treatment.
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Warren Grant Magnuson Clinical Center (CC)