Protocol Number: 04-C-0083
Patients 16 years of age and older with Stage IV melanoma may be eligible for this study. Candidates are screened with a physical examination, eye examination, blood and urine tests, electrocardiogram, and imaging studies (x-rays and scans) to check the size and extent of tumor. Some candidates may have lung function studies, if medically indicated. Patients' tissue type is determined with a blood test. Participants with HLA-A*0201 positive tissue type are randomly assigned to receive or not to receive the gp100 peptide vaccine along with the MDX-010. Participants with HLA-A *0201 negative tissue type will receive MDX-010 alone. Patients get MDX-010, with or without vaccine, every 3 weeks. The dose is increased (up to 9 mg/kg body weight) every other treatment until the patient's tumor shrinks or a severe autoimmune reaction develops. MDX-010 is given intravenously (IV) over 90 minutes through a catheter (plastic tube) placed in a vein. The vaccine is given in four injections under the skin of the thighs or arms. Blood is drawn before and after each treatment to measure MDX-010 levels in the blood. Other blood tests and a physical examination are done before each treatment and at each clinic visit to look for changes in the blood that signal reactions to the vaccine or antibody, and to check for side effects. Patients who have complete tumor shrinkage or whose tumors begin to shrink and then stabilize get two additional treatments at the dose level that resulted in tumor shrinkage. Further treatment is stopped and the patient is followed with scans. Patients who develop severe side effects from the treatment are taken off the study and their symptoms are treated. Patients also undergo plasmapheresis-a procedure to collect quantities of white blood cells-before treatment begins and possibly again after every two treatments. For this procedure, blood is drawn through a needle in the arm and circulated through a machine that spins it to separate the components. The white cells are removed and the plasma and red cells are returned through a needle in the other arm. Some patients may also have a biopsy of their tumor or lymph node tissue to examine the effects of the vaccine on the tumor immune cells. This involves drawing a small amount of tissue through a needle injected in the skin. Patients return to the clinic 3 weeks after each treatment for a physical examination and blood tests prior to receiving the next treatment After every two treatments, patients have scans to re-evaluate the tumor size and discuss options for further treatment, at the next higher dose.
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