Vaccine Therapy for HER2+ Stage IV Breast Cancer
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
|Closed||Breast Cancer||Phase II||
This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Eligibility Criteria (must meet the following to participate in this study)
- Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission
- Patients must have stable measureable disease as follows: extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) scan and/or skeletal disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) scan
- 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
- White blood cell (WBC) > 3000/mm^3
- Hemoglobin (Hgb) > 10 mg/dl
- Platelets > 100,000/mm^3
- Subjects of reproductive ability must agree to use contraceptives during the entire study period
Exclusions (conditions that would prevent participation in this study)
- Serum creatinine > 2.0 mg/dl
- Total bilirubin > 1.5 x upper limit of normal
- 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)
- Contraindication to receiving sargramostim (GM-CSF) based vaccine products
- Active brain metastasis
Last UpdatedOctober 08, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.