Vaccine Therapy in Treating Patients With Stage IV Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
In brief
This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)
Key facts
- Study ID
- NCT00791037
- Run by
- University of Washington
- People needed
- 23
- Starts
- 2008-10-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-05-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with HER2+ Stage IV breast cancer that have been maximally treated and not achieved a complete remission
- Patients must have stable or slowly progressive disease state, measurable disease as:
- Extraskeletal disease that can be accurately measured >= 10 mm by standard imaging techniques that can include but not limited to computed tomography (CT), positron emission tomography (PET), PET/CT, magnetic resonance imaging (MRI);
- Skeletal or bone-only disease which is measurable by fludeoxyglucose (FDG) PET or PET/CT imaging will also be allowed
- Patients can be currently 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 2+ or 3+, or documented gene amplification by fluorescence in situ hybridization (FISH) analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
- Subjects must have a Performance Status Score (Southwest Oncology Group [SWOG]/Zubrod Scale) = 0, 1 or 2
- Patients must be off all immunosuppressive treatments such as chemotherapy or systemic steroid therapy a minimum of 14 days prior to initiation of study (i.e. first vaccination)
- Patients on trastuzumab and/or lapatinib must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) equal to or greater than the lower limit of normal for the facility within 90 days of eligibility determination
- Men and women of reproductive ability must agree to contraceptive use during the entire study period
- Patients must have an expected survival of 6 months
- White blood cell (WBC) >= 3000/mm\^3
- Absolute neutrophil count (ANC) >= 1000/mm\^3
- Hemoglobin (Hgb) >= 10 mg/dl
- Platelets >= 75,000/mm\^3
- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
- Total bilirubin =< 2.5 mg/dl
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 times upper limit of normal (ULN)
- Patients must be >= 18 years old
You may not qualify if…
- Patients with any of the following cardiac conditions:
- Symptomatic restrictive cardiomyopathy;
- Unstable angina within 4 months prior to enrollment;
- New York Heart Association functional class III-IV heart failure on active treatment
- Patients with any contraindication to receiving rhuGM-CSF based products
- Patients with any clinically significant autoimmune disease uncontrolled with treatment
- Patients with a history of brain metastases must have a stable head imaging study within 30 days of eligibility determination; specifically, patients with active brain metastases will not be eligible for study
- Patients who are simultaneously enrolled in any other treatment study
- Pregnant or breast-feeding women
Where it is running
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.