Protocol Number: 07-C-0188
-New treatment options are needed for patients with prostate cancer whose prostate-specific antigen (PSA) levels rise after surgery or radiation therapy. -Onyvax is an experimental vaccine designed to help the immune system recognize and attack cancer cells. -Hormonal therapy with the drug goserelin stops testosterone production in the body. This treatment can kill prostate tumor cells and lower PSA levels, and may help increase immune responses to Onyvax vaccine. Objectives: -To determine the safety and effectiveness of Onyvax vaccine therapy following hormonal therapy in patients with prostate cancer. -To determine if treatment with Onyvax vaccine following hormonal therapy can delay a rise in PSA. Eligibility: -Men with a rising PSA level following localized surgery or radiation therapy for prostate cancer. -Normal testosterone level. -No evidence of disease on CT or bone scan. Design: -Patients are treated with hormone therapy (goserelin) for 3 months. Following hormonal therapy, patients are randomly assigned to receive either Onyvax vaccine or placebo vaccine. Vaccines are given as an injection on days 1, 15, and 29, and then every 4 weeks for up to 52 weeks. -Before treatment begins, patients have a medical history and physical examination, blood and urine tests, a bone scan, and a CT scan of the pelvis and abdomen. Physical examination and blood and urine tests are repeated before each injection and at the end of the study. -Patients who have the HLA-A2 tissue type undergo apheresis, a process for obtaining white cells. Whole blood is collected through a tube (similar to donating blood) and flows through a cell-separator machine. The white cells are extracted for immune studies and the rest of the blood (platelets, red cells, and plasma) is returned to the body.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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