Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT00807781
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The purpose of this study is to evaluate the safety of mammaglobin-A DNA vaccine in metastatic breast cancer patients.
- Detailed Description
This is a phase I open-label study to evaluate the safety and immunogenicity of a plasmid mammaglobin-A DNA vaccine. The plasmid mammaglobin-A DNA vaccine will be formulated as a naked plasmid DNA vaccine (WUSM-MGBA-01). The hypothesis of this study is that the mammaglobin-A DNA vaccine will be safe for human administration and capable of generating measurable CD8 T cell responses to mammaglobin-A. The primary objective of this study is to demonstrate the safety of the mammaglobin-A DNA vaccine. The secondary objective is to evaluate the immunogenicity of the mammaglobin-A DNA vaccine as measured by ELISPOT analysis, a surrogate for CD8 T cell function.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate safety of mammaglobin-A DNA vaccine, WUSM-MGBA-01 30 days after completion of treatment
- Secondary Outcome Measures
Name Time Method To evaluate the immunogenicity of the mammaglobin-A DNA vaccine, WUSTL-MGBA-01. Immunogenicity will be measured by ELISPOT analysis, a surrogate for CD8 T cell function. 52 weeks
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Washington University School of Medicine🇺🇸St. Louis, Missouri, United States