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Complete title: Phase II Study to Evaluate the Development of HER2/neu (HER2)-Specific Memory T Cells after HER2 Peptide-Based Vaccination in Patients with Advanced Stage HER2+ Breast Cancer
|Research Study Number||7905|
|Principal Investigator||Lupe Salazar, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission
- Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:
--- Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques
-- Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI)
- Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy
- HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis
- Patients must be human leukocyte antigen (HLA)-A2 positive
- Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1
- Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine
- Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study
- Subjects of reproductive ability must agree to use contraceptives during the entire study period
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Hemoglobin (Hgb) < 10 mg/dl
- Platelets < 100,000/mm^3
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin > 1.5 x upper limit of normal
- Any contraindication to receiving sargramostim (GM-CSF) based vaccine products
- Concurrent enrollment in other treatment studies
- New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina
- Pregnant or breast-feeding women
- History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV)
- Active brain metastasis
Other exclusion criteria may apply.
Breast Cancer; Solid Tumors
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