Protocol Number: 00-C-0074
Patients 16 years of age and older with progressive metastatic ocular melanoma and for whom standard treatments no longer work may be eligible for this study. Candidates will be screened with a complete physical and examination, including an eye examination, blood and urine tests, chest X-ray, electrocardiogram, X-ray and nuclear medicine imaging scans to evaluate the size and extent of tumor, and, if needed, a cardiac stress test and lung function test. In addition, patients will be tested for their HLA tissue type; patients must be type HLA-A*0201, the type on which this vaccine is based. Participants will receive two injections of both peptide vaccines (a total of four shots) in the thigh each week for 4 weeks. 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. Patients will also undergo plasmapheresis-a procedure to collect white blood cells-before treatment begins, after the second vaccination and 3 weeks after the fourth vaccination. 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 white cells (immune system cells), and the rest of the blood is returned through a needle in the other arm. Patients return for follow-up 3 to 4 weeks after the fourth injection. Patients in whom disease has not progressed or whose tumor has shrunk may receive additional 4-week treatment courses for up to 6 courses (24 immunizations). Patients whose tumor has not responded to therapy and who are physically eligible to receive a substance called interleukin-2 (IL-2) may receive a second series of vaccines together with this agent. IL-2 may boost the immune response to the peptides. It is given intravenously (through a small tube placed in a vein) every 8 hours for 5 days after each vaccination. Patients who respond to the vaccine and IL-2 may be offered additional courses of this treatment regimen.
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