Protocol Number: 03-C-0299
Patients 16 years of age and older with metastatic melanoma (melanoma that has spread beyond the original tumor site) that is not responding to conventional treatment may be eligible for this study. Candidates will be screened with a physical examination and blood and urine tests. An electrocardiogram (EKG), x-rays and other imaging studies will be done if recent results are not available. Some candidates may require heart tests, such as a cardiac stress test or echocardiogram, or lung function tests. In addition, all candidates will be tested for HLA tissue type. All patients will receive the gp100 protein vaccine. Patients who have tissue type HLA-A0201 will be randomly assigned to receive either 1) the gp100 protein alone, or 2) the gp100 protein plus gp100 peptide (a peptide is a part of the protein). Each treatment consists of four vaccine injections every 3 weeks for four times. The shots are given under the skin of the thigh. At each clinic visit, patients are monitored with blood tests and physical examinations to look for treatment side effects. Patients also undergo leukapheresis-a procedure to collect white blood cells-to evaluate how the vaccines affect the action of the immune system cells. For this procedure, blood is drawn through a needle in the arm, similar to donating blood. The blood goes through a machine that separates out the lymphocytes (white blood cells), and the rest of the blood is returned through a needle in the other arm. In addition, some patients may undergo a biopsy-surgical removal of a small piece of tissue under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects of the vaccines on the tumor immune cells. Three to four weeks after completing the course of injections, patients have a physical examination and scans to evaluate the tumor's response to treatment. Patients whose tumors have stabilized or shrunk may continue immunizations for up to 12 months total (another 3 courses). Patients whose disease has not improved after the first course of therapy and who have not previously received high-dose interleukin-2 (IL-2) treatment may then be given protein plus peptide along with IL-2 if they meet the criteria for administration of IL-2. This substance may increase the immune reaction to the vaccine. IL-2 is given intravenously (through a small tube placed in a vein) every 8 hours for up to 4 days after each vaccine injection. It will be repeated every 3 weeks for four times (one treatment course). IL-2 therapy requires a 1-week hospital admission. Patients whose tumors respond to this therapy may receive a total of four courses of vaccinations plus IL-2. Patients whose disease does not respond to therapy or recurs after treatment will be taken off the study and will be referred back to their referring physician or to another study, if an appropriate one is available.
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