Status:
COMPLETED
Study of Cancer Peptides Vaccine Plus GM-CSF as Adjuvant Treatment for High Risk (TXN2-3M0) or Metastatic Breast Cancer With No Evidence of Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
Immunotope
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and feasibility of administering a peptide vaccine consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0) or metastatic breas...
Detailed Description
The primary endpoint will be to determine the safety and feasibility of administering cancer peptides to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease foll...
Eligibility Criteria
Inclusion
- HLA-A2 patients with histologically confirmed, TxN2-3M0 or metastatic breast cancer with no evidence of disease who have completed their adjuvant systemic chemotherapy or trastuzumab
- Subjects will not be treated until 4 or more weeks after any prior chemotherapy, radiation therapy or immunotherapy, but they may be receiving hormonal therapy
Exclusion
- History of autoimmune disease
- Serious intercurrent chronic or acute illness
- Active hepatitis
- Serologic evidence for HIV, splenectomy
- Receiving steroid or immunosuppressive therapy
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00674791
Start Date
June 1 2007
End Date
January 1 2010
Last Update
June 19 2013
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710