Clinical Trials Using Multi-epitope TARP-pulsed Autologous Dendritic Cell Vaccine
Clinical trials are research studies that involve people. The clinical trials on this list are studying Multi-epitope TARP-pulsed Autologous Dendritic Cell Vaccine. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer
Background: - Men who continue to have an elevated or rising prostate specific antigen (PSA) level after their primary prostate cancer treatment are at increased risk for their cancer to progress. The time it takes to progress is highly variable. One way to predict this progression is based on the change in PSA levels over time. This is called the PSA doubling time (PSADT). Researchers want to test a vaccine on men with Stage D0 prostate cancer. Stage D0 means the PSA has become detectable again or has started to rise after primary treatment, but has not spread to other organs. Objectives: - To test a vaccine s effectiveness on the rate of PSA increase using PSADT and tumor growth rates. Eligibility: - Men with Stage D0 prostate cancer with a PSADT between 3 and 15 months. Design: - Participants will be screened with blood tests, scans, physical exam, and medical history. Their prostate cancer will be confirmed. - Participants will undergo apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm. - Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects. - Participants will get injections of either the vaccine or placebo at weeks 3, 6, 9, 12, 15, and 24. Both will be made from the participants own cells. - Participants will be selected randomly to receive either active vaccine or placebo. For every two participants assigned to active vaccine, one participant will be assigned to placebo vaccine. - Participants will get a Vaccine Report Card to to complete after receiving vaccine. - The study lasts 96 weeks.
Location: 2 locations