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

NCT ID: NCT01729884

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31

Brief Summary

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.

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.

Conditions

HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (HER-2/neu peptide vaccine)

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

Group Type: EXPERIMENTAL

HER-2/neu peptide vaccine

Intervention Type: BIOLOGICAL

Given ID

Interventions

HER-2/neu peptide vaccine

Given ID

Intervention Type: BIOLOGICAL

Other Intervention Names

HER-2

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Mary (Nora) Disis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lupe Salazar

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2012-02223

Identifier Type: REGISTRY

Identifier Source: secondary_id

7905

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50CA138293

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7905

Identifier Type: -

Identifier Source: org_study_id