Protocol Number: 99-C-0138
Many breast and ovarian cancer patients have an altered (mutated) gene called p53 that causes the production of abnormal proteins found in their tumor cells. The body's immune system may try, unsuccessfully, to fight these abnormal proteins. In this study, breast cancer patients with a p53 abnormality will be vaccinated with a p53 peptide-a part of the same abnormal protein found in their tumor-to try to boost their body's immune response to the cancer. Patients will be divided into two groups. Group A will have four p53 peptide vaccinations three weeks apart, injected under the skin. The injection will include a drug called ISA-51, which increases the effect of the vaccine. This group will also receive two other drugs that boost the immune system, IL-2 and GM-CSF. Group B will have four p53 peptide vaccinations three weeks apart. The peptide will be mixed with the patient's own blood cells and infused into a vein. This group will also receive IL-2, but not GM-CSF. All study candidates will be tested to see if their cancer has a p53 abnormality and if their immune system mounted a defense against it. These tests may include a tumor biopsy (removal of a small part of the tumor for microscopic examination); lymphapheresis (a procedure to take blood, remove white blood cells called lymphocytes, and return the red cells); and an immune response test similar to a skin test for tuberculosis. During the study, patients will have additional skin tests and blood tests.
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Warren Grant Magnuson Clinical Center (CC) |
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