Spots Global Cancer Trial Database for Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer
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Trial Identification
Brief Title: Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer
Official Title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Mammaglobin-A DNA Vaccine in Breast Cancer Patients With Metastatic Disease
Study ID: NCT00807781
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Washington University School of Medicine, St. Louis, Missouri, United States
Contact Details
Name: William Gillanders, M.D.
Affiliation: Washington Univerisity School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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