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Complete title: Phase I/II Study of Adoptive T Cell Therapy Following In Vivo Priming With a HER-2/neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine in Patients With Advanced Stage HER2 Overexpressing Breast Cancer
|Research Study Number||6658|
|Principal Investigator||Nora Disis, MD|
Research Study Description
- To evaluate how safe giving escalating doses of T cells into patients with advanced HER2-positive breast cancer is.
- To look at how much HER2 specific T cell immunity can be boosted or generated in patients.
Eligibility Criteria (must meet the following to participate in this study)
- Patients with HER2-positive Stage IV breast cancer that have been maximally treated and not achieved a complete remission
- Patients must have stable or slowly progressive disease, measurable as described below:
-- a) Extraskeletal disease that can be accurately measured = 10 mm by standard imaging techniques that can include but not limited to CT, PET, PET/CT, MRI
-- b) Skeletal or bone-only disease which is measurable by FDG PET or PET/CT imaging will also be allowed
- Patients can be currently receiving trastuzumab (herceptin) and/or lapatinib (Tykerb) and/or hormonal therapy and/or bisphosphonate therapy
- HER2 overexpression in the primary tumor or metastasis by:
-- a) IHC of 2+ or 3+, or
-- b) Documented gene amplification by fluorescence in situ hybridization (FISH) analysis
-- c) If overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
- Subjects must have a Performance Status Score (SWOG/Zubrod Scale) = 0- 2
- Patients must be off all immunosuppressive treatments such as chemotherapy or systemic steroid therapy a minimum of 14 days prior to the first vaccination
- Patients on trastuzumab (herceptin) and/or lapatinib (Tykerb) must have a baseline LVEF measured by MUGA or echocardiogram (ECHO) equal to or greater than the lower limit of normal for the facility within 90 days of eligibility determination
- Subjects must be = 18 years old
- 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/mm3
- Absolute neutrophil count (ANC) = 1000/mm3
- Hemoglobin (Hgb) = 10 mg/dl
- Platelets = 75,000mm3
- 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 ULN
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Patients with any of the following cardiac conditions:
-- a) symptomatic restrictive cardiomyopathy
-- b) unstable angina within 4 months prior to enrollment
-- c) 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
Other exclusion criteria may apply.
Breast Cancer; Solid Tumors
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