Status:
COMPLETED
Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer
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 objectives of this study are the following: 1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75) in node-negative breast cancer patients. 2. To determine the ...
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
- Breast cancer and negative lymph nodes
- HLA-A2+ and/or HLA-A3+ to receive the vaccine. HLA-A2-, HLA-A3- patients will be eligible to be included in the control group.
- Immunologically intact with a good performance status (defined below).
- Without evidence of disease.
- Patients may enroll while receiving appropriate hormonal therapy for their disease.
- Completion of all standard first-line therapies (but may still be on hormonal therapy)
Exclusion
- HLA-A2- and/or HLA-A3- patients will not be vaccinated
- Anergic by the Mantoux panel of recall antigens
- Receiving immunosuppressive therapy
- In poor health (Karnofsky \<60%, ECOG \>2)
- Tbili \>1.5 mg/dL and creatinine\>2 mg/dL
- Pregnancy (urine HCG)
- Active metastatic disease
- Involved in other experimental protocols (unless approval is first obtained by the other study PI)
- Refusal of standard therapies
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00854789
Start Date
December 1 2002
End Date
March 1 2013
Last Update
March 31 2020
Active Locations (2)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307-5001
2
Windber Medical Center
Windber, Pennsylvania, United States, 15963