Status:
COMPLETED
Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III Breast Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is most effective in treating breast cancer. PURPOSE...
Detailed Description
OBJECTIVES: Primary * To determine the safety and immunization efficacy of MUC1 and HER-2/neu peptide vaccines combined with CpG oligodeoxynucleotide, sargramostim (GM-CSF), or both, as immune adjuv...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Clinical stage II or III disease
- No radiographic evidence of disease at the time of enrollment
- Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy
- Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease
- Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met:
- HER2 over-expression or amplification
- Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining)
- .
- MUC1-positive breast cancer
- HLA-A2 positive
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-2
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 75,000/μL
- ANC ≥ 1,500/uL
- Creatinine ≤ 2 times upper limit of normal (ULN)
- AST ≤ 2 times ULN
- No uncontrolled infection
- No known HIV infection
- No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Fully recovered from acute, reversible effects of any prior breast cancer therapy
- No more than 3 years since prior surgery for primary breast cancer
- Concurrent anti-estrogen therapy is allowed
- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
- No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent
Exclusion
Key Trial Info
Start Date :
August 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00640861
Start Date
August 28 2008
End Date
April 21 2015
Last Update
October 31 2018
Active Locations (3)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
2
Mayo Clinic in Florida
Jacksonville, Florida, United States
3
Mayo Clinic
Rochester, Minnesota, United States, 55905