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Protocol Number: 06-C-0069 
Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue type is tested as being HLA-A2, through a specific blood test, may be eligible for this study.
Up to 145 participants will be enrolled. There will be a physical examination and collection of blood samples for tests, and making sure that x-rays and scans are current. Patients will be assigned to groups 5-6 by chance, like a flip of a coin ; a process called randomization. Patients are being randomized to groups 5 and 6 which were recently added since preliminary results from the other groups indicate that the peptide was not immunizing. We believe this is due to non-optimal preparation of the peptide and adjuvant. Therefore, groups 5 and 6 were added with a new way of preparation of the peptide and adjuvant which others have shown to immunize. Group 1 will receive the peptide with an adjuvant (assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2 will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for treating genital warts and herpes but that may help immune cells in the skin to recognize the vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed in salt water given as several mini-doses under the skin of the thigh. Group 4 will also receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to the skin for 5 days. Group 5 will receive the peptide with an adjuvant oil-based liquid called "Montanide ISA-51 VG"(Montanide). This adjuvant (or "assistant") is intended to increase the reaction of your immune system to the peptide. This will be given as an injection in your thigh. The peptide and adjuvant will be mixed using 2 syringes. Group 6 will receive gp100, Montanide (as an injection in your thigh) and a cream called imiquimod applied to the skin for 5 days. Imiquimod has been approved by the U.S. Food and Drug Administration (FDA) for treatment of superficial basal carcinoma, actinic keratosis, genital warts and herpes and we think that this drug may help the immune cells in your skin recognize the vaccine, but we do not know this for certain. The peptide and adjuvant will be mixed using 2 syringes. All patients will receive the gp100 every 3 weeks for 12 weeks. Every dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not return or patients do not experience side effects from this therapy, then the courses of vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects of the peptide vaccination include local swelling, swelling of local lymph nodes, bruising, and pain and redness at the injection sites. There may be chills or fever. Patients will be watched closely for such side effects. To study how the vaccine changes the action of cells in the immune system, patients' white blood cells (lymphocytes) will be obtained, involving a separate informed consent. The procedure, called leukaphersis, requires inserting a needle into the arm, to obtain blood going into a machine, which divides the blood into red cells, plasma (or the serum part), and lymphocytes. The lymphocytes are removed, and the plasma and red cells returned to the patient through a second needle in the other arm. Risks associated with the procedure include fainting, which can be prevented by patients' eating before coming to the lab, and bleeding and infection at the needle site. Patients will undergo leukapheresis will be done about four times: before receiving the vaccine, 3 weeks after the first four doses, and then after 8 cycles and 12 cycles. Patients assigned to the groups receiving imiquimod will be asked to record every time they apply that cream and describe any symptoms developed during the study. All patients will be watched closely for any sign that their melanoma has returned. Before and throughout the study, multiple blood tests will be conducted.
The vaccine, Montanide, and imiquimod may increase patients' immune system in fighting off new tumors, but that is not known now. However, the study may provide information that will be useful in treating melanoma patients in the future.
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National Institutes of Health Clinical Center