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Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington Identifier:
First received: November 13, 2008
Last updated: September 6, 2016
Last verified: September 2016
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)

Condition Intervention Phase
HER2-positive Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Biological: HER-2/neu peptide vaccine
Procedure: leukapheresis
Biological: ex vivo-expanded HER2-specific T cells
Drug: cyclophosphamide
Biological: sargramostim
Other: laboratory biomarker analysis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Safety and systemic toxicity of infusing HER2-specific T cells as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 [ Time Frame: Up to 4 months after first booster vaccine ]
    Defined as safe if at least 75% of patients are able to receive all 3 infusions without dose-limiting toxicity (DLT), any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding constitutional, pulmonary, or dermatology/skin categories) or any incidence of Grade 4 toxicity (excluding reversible Grade 4 blood/bone marrow category after cyclophosphamide).

Secondary Outcome Measures:
  • Proportion of patients whose T cells persist at a level the same or greater as the level after the final T cell infusion and subsequent booster immunizations as assessed by IFN-gamma (IFN-g) ELISPOT [ Time Frame: Up to 2 year following the last infusion ]
  • Development of CD4+ and CD8+ epitope spreading [ Time Frame: Up to 2 years ]
    As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.

  • Response of skeletal or bone-only disease by FDG-PET and according to European Organization for Research and Treatment for Cancer (EORTC) [ Time Frame: Up to 2 years ]

Estimated Enrollment: 20
Study Start Date: October 2008
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (vaccine therapy)

Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.

Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.

Biological: HER-2/neu peptide vaccine
Given ID
Other Name: HER-2
Procedure: leukapheresis
Undergo leukapheresis
Biological: ex vivo-expanded HER2-specific T cells
Given IV
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Biological: sargramostim
Given ID
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
Other: laboratory biomarker analysis
Correlative study

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00791037

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Mary Disis Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Washington Identifier: NCT00791037     History of Changes
Other Study ID Numbers: 6658
NCI-2009-01591 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R01CA129517 ( US NIH Grant/Contract Award Number )
Study First Received: November 13, 2008
Last Updated: September 6, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists processed this record on April 25, 2017