Status:
WITHDRAWN
Ex Vivo-Expanded HER2-Specific T Cells and Cyclophosphamide After Vaccine Therapy in Treating Patients With HER2-Positive Stage IV Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2-positive Breast Cancer
Male Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the feasibility of expanding HER-2-specific effector T cells (TE) ex vivo from CD62L+ TCM and CD62L- TEM from patients immunized with a HER-2 peptide vaccine. II. ...
Eligibility Criteria
Inclusion
- Patients with HER-2+ Stage IV breast cancer that have been maximally treated and not in a complete remission
- Subjects must be \> 18 years old
- Extra skeletal disease that can be accurately measured in at least one dimension as \>= 20 mm with conventional CT techniques or \>= 10 mm with spiral CT scan
- Skeletal or bone-only disease that is measurable by FDG PET imaging will also be allowed
- Patients can be receiving trastuzumab and/or hormonal therapy and/or bisphosphonates
- HER2 overexpression in the primary tumor or metastasis by IHC of 2+ or 3+, or documented gene amplification by FISH analysis; if over expression is 2+ by IHC, patients must have HER2 gene amplification documented by FISH
- Performance Status Score (ECOG/Zubrod Scale) must be =\< 2
- Patients must be off all immunosuppressive treatments such as chemotherapy or systemic steroid therapy a minimum of 3 weeks prior to initiation of study (i.e. first vaccination)
- Patients on trastuzumab must have a baseline LVEF measured by MUGA or echocardiogram \>= the lower limit of normal for the facility within 3 months of enrollment to study
- Subjects must be HLA-A2 (HLA A\*0201) positive
- ANC \>= 1000/mm\^3
- Hgb \>= 10 mg/dl
- Platelet count \>= 75,000/mm\^3
- Men and women of reproductive ability must agree to use contraceptives during the entire study period
Exclusion
- Serum creatinine \> 2.0 mg/dl
- Serum bilirubin \> 2.5 times the upper limit of normal
- Contraindication to receiving GM-CSF based vaccine products
- New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina
- History of disorders associated with immunosuppression such as HIV
- Pregnant or breast-feeding women
- ANC \< 1000/mm\^3
- Hgb \< 10 mg/dl
- Platelet count \< 75,000/mm\^3
- Active brain metastasis
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01219907
Start Date
June 1 2012
Last Update
May 17 2013
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109