Mammaglobin-A DNA Vaccine for Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00807781|
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : January 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Biological: Mammaglobin-A DNA vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2009|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Mammaglobin-A DNA vaccine
Patients will receive vaccine day 1 (week 1), week 4 (day 29 +/- 7), week 8 (day 57 +/- 7) with at least 21 days between injection days.
All injections will be given intramuscularly using a jet delivery device.
Patients will be administered the vaccine in lateral shoulder and buttocks positions that will be rotated with each administration in the above order.
|Biological: Mammaglobin-A DNA vaccine|
- Evaluate safety of mammaglobin-A DNA vaccine, WUSM-MGBA-01 [ Time Frame: 30 days after completion of treatment ]
- 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. [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807781
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||William Gillanders, M.D.||Washington Univerisity School of Medicine|