Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01729884
First received: November 15, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.


Condition Intervention Phase
HER2-positive Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Biological: HER-2/neu peptide vaccine
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Development of HER2/Neu (HER2)-Specific Memory T Cells After HER2 Peptide-based Vaccination in Patients With Advanced Stage Her2+ Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Quantification and characterization of HER2-specific TCM and TEM subsets in PBMC [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Wilson score 90% confidence intervals will be reported.

  • Evaluation of function and phenotype of HER2-specific TE cells derived from HER2-specific TCM and TEM subsets [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Wilson score 90% confidence intervals will be reported. Determined by flow cytometry and reported using descriptive statistics and graphical summaries.


Secondary Outcome Measures:
  • The number of subjects reporting adverse events, evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    All, severe or worse, serious and related events will be quantified.

  • The percent of subjects recording adverse events, evaluated according to the CTEP CTCAE version 4.0 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    All, severe or worse, serious and related events will be quantified.


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once monthly for 3 months.
Biological: HER-2/neu peptide vaccine
Given ID
Other Name: HER-2
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To quantify and characterize human epidermal growth factor receptor 2 (HER2)-specific central memory T cell (TCM) and effector memory T cell (TEM) subsets in peripheral blood mononuclear cell (PBMC) of patients vaccinated with a HER2 cytotoxic T lymphocyte (CTL) peptide-based vaccine.

II. To evaluate the feasibility of expanding HER2-specific effector T cells (TE) derived from HER2-specific TCM or TEM precursors in patients vaccinated with a HER2 CTL peptide-based vaccine and characterize their function.

SECONDARY OBJECTIVES:

I. To evaluate the safety of administering a HER2 CTL peptide-based vaccine in patients who are receiving trastuzumab and/or lapatinib (lapatinib ditosylate).

OUTLINE:

Patients receive HER-2/neu peptide vaccine intradermally (ID) once monthly for 3 months.

After completion of study treatment, patients are followed up at 4 weeks.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission
  • Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:

    • Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques
    • Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI)
  • Patients can be 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 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis
  • Patients must be human leukocyte antigen (HLA)-A2 positive
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1
  • Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine
  • Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study
  • Subjects of reproductive ability must agree to use contraceptives during the entire study period

Exclusion Criteria:

  • White blood cell (WBC) < 3000/mm^3
  • Hemoglobin (Hgb) < 10 mg/dl
  • Platelets < 100,000/mm^3
  • Serum creatinine > 2.0 mg/dl
  • Serum bilirubin > 1.5 x upper limit of normal
  • Any contraindication to receiving sargramostim (GM-CSF) based vaccine products
  • Concurrent enrollment in other treatment studies
  • New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina
  • Pregnant or breast-feeding women
  • History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV)
  • Active brain metastasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729884

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Lupe G. Salazar    206-616-8503      
Principal Investigator: Lupe G. Salazar         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Lupe Salazar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01729884     History of Changes
Other Study ID Numbers: 7905, NCI-2012-02223, 7905, P30CA015704, P50CA138293
Study First Received: November 15, 2012
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014