At a glance
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A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/Neu ECTM in Adults With Tumors With 1-3+ HER2/Neu Expression
In Brief
A Phase 1 clinical trial evaluating Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine for Breast Neoplasms and 3 related conditions. Completed, enrolled 33 participants across 1 site.
Detailed Summary
Background: \- Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in several other types of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates, and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune system to recognize HER2. The vaccine, called adenoviral transduced autologous human epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an individual's own immune cells. These cells will be collected and used to produce the vaccine. Objectives: \- To test the safety and effectiveness of AdHER2 vaccination. Eligibility: \- Individuals at least 18 years of age who have HER2-expressing tumors. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed. * Participants will have an apheresis procedure to collect immune cells to create the vaccine. * Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24. * Participants will be monitored with physical exams, frequent blood tests and imaging studies.
Study Details
Timeline
Interventions
autologous AdHER2 transduced dendritic cell vaccine manufactured under Good Manufacturing Practices (GMP) conditions from cryopreserved patient monocytes here at the National Institutes of Health (NIH) Clinical Center (CC) Department of Transfusion Medicine (DTM). Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16 and 24 of the study.