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
A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA 51) Following Completion of Prescribed Chemotherapy or Trastuzumab for TXN2-3M0 or Metastatic Breast Cancer With No Evidence of Disease
1 other identifier
interventional
13
1 country
1
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 breast cancer with no evidence of disease following their completion of systemic therapy. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 breast-cancer
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 5, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJune 19, 2013
March 1, 2011
2.6 years
May 5, 2008
June 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations.
Status post-3 immunizations
Secondary Outcomes (1)
Immunologic response: Number of subjects with tumor antigen specific immune response after 3 immunizations.
Status post-3 immunizations
Interventions
Patients will receive 1 injection into each thigh at each of 6 visits: week 0, week 1, week 2, week 4, week 5, and week 6. The first 9 patients will receive a 100 microgram dose and the second 9 patients a 1 milligram dose of the peptide mixture.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of autoimmune disease
- Serious intercurrent chronic or acute illness
- Active hepatitis
- Serologic evidence for HIV, splenectomy
- Receiving steroid or immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Immunotopecollaborator
Study Sites (1)
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Morse, M.D.
Duke University Cancer Center
- PRINCIPAL INVESTIGATOR
Kimberly Blackwell, M.D.
Duke University Cancer Center
Ramila Philip, Ph.D.
Immunotope
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 5, 2008
First Posted
May 8, 2008
Study Start
June 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
June 19, 2013
Record last verified: 2011-03