Overview

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
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)
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Sargramostim
Vaccines
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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