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You can access this
clinical trial
if you have
Breast Neoplasms, Breast Cancer, Adenocarcinomas or Metastatic Solid Tumors Characterized by HER2/Neu Expression
and you are
between 18 and 99
years old
Phase
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Background: - HER2/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 AdHER2/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 four doses of the vaccine at study Weeks 0, 4, 8, and 24. - Participants will be monitored with physical exams, frequent blood tests and imaging studies.

Provided treatments

  • Biological: Autologous Ad HER2 dendritic cell vaccine
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Locations near you

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Tris trial is registered with FDA with number: NCT01730118. The sponsor of the trial is National Cancer Institute (NCI) and it is looking for 65 volunteers for the current phase.
Official trial title:
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