Status:
COMPLETED
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients
Lead Sponsor:
COL George Peoples, MD, FACS
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purposes of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) 2. To determine maximum tolerated dose (MTD) and optimal biolog...
Detailed Description
Breast cancer is the most common malignancy and second most common cause of cancer-specific death among women in the United States. Despite advances in the diagnosis and treatment of breast cancer, on...
Eligibility Criteria
Inclusion
- HER2/neu expressing tumor
- HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2- and/or HLA-A3- patients will be eligible to be included in the control group.
- Immunologically intact with a good performance status
- Identified as being high or intermediate risk for recurrence
- Without evidence of disease
- Completion of all standard first-line therapies (but may still be on hormonal therapy)
Exclusion
- Tumor does not express HER2/neu
- Not HLA-A2+ and/or HLA-A3+
- Anergic
- Receiving immunosuppressive therapy
- In poor health (Karnofsky \<60%, ECOG \>2 and Tbili \>1.5 and creatinine\>2)
- Pregnant (beta HCG+)
- Metastatic disease or have refused standard therapies
- Patients enrolled in other experimental protocols may enroll to this study only with the permission of the other study PI.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00841399
Start Date
July 1 2001
End Date
March 1 2013
Last Update
March 31 2020
Active Locations (2)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
2
Windber Medical Center
Windber, Pennsylvania, United States, 15963