Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2

Development of HER-2/Neu (HER2) ICD Memory Immunity After Vaccination With a Plasmid Encoding HER2 ICD in Patients With Advanced Stage HER2 Overexpressing Breast and Ovarian Cancers

RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2.

PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: HER-2/neu intracellular domain protein; Other: flow cytometry; Other: immunohistochemistry staining method; Procedure: biopsy; Other: Sterile water placement

Detailed Description

OBJECTIVES:

Primary

• Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine by assessing the delayed-type hypersensitivity response to HER2 ICD peptides 6 months after vaccination in patients with HER2-overexpressing stage III or IV breast cancer.

Secondary

• Characterize the memory T-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining.

OUTLINE: This is an open-label study.

Patients receive HER2 intracellular domain (ICD) protein mixture intradermally and sterile water injected intradermally (as a negative control) at 6 months post-vaccination with pNGVL3-hICD vaccine. Vital signs and injection site will be monitored prior to skin test and at 60 minutes post-test. Patients return 48-72 hours after skin test for delayed-type hypersensitivity (DTH) measurements. The injection site is biopsied and examined by immunohistochemistry for infiltrating T-cell and antigen-presenting cell populations.

Blood is drawn at 3, 6, and 12 months post-vaccination for assessment of immune memory response. Blood draws are coordinated with parent study. Blood samples are examined by flow cytometry for the presence of memory markers including L-selectin, CD45 isoforms, cytokines, and CCR7.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    • Seattle, Washington, United States, 98109
      • Tumor Vaccine Group at the University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Diagnosis of stage III/IV breast cancer

  • Completed chemotherapy
  • Receiving trastuzumab (Herceptin®) monotherapy
• Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female (male patients are not excluded)
• Menopausal status not specified
• Zubrod performance status 0
• Unable to bear children (female patients)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No cytoreductive chemotherapy within the past 30 days
• No cytotoxic treatment and/or systemic corticosteroids within the past month
• Concurrent local radiotherapy or hormonal therapy allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein	6 months after active immunization

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterization of memory T-cell population by intracellular cytokine staining	3, 6, and 12 months after active immunization
Quantitate memory precursor frequency by intracellular cytokine staining	3, 6, and 12 months after active immunization

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lupe G. Salazar, MD, Tumor Vaccine Group at the University of Washington

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: August 10, 2006
• First Submitted That Met QC Criteria: August 10, 2006
• First Posted (ESTIMATE): August 15, 2006

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; male breast cancer; stage IIIC breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 6271; P30CA015704 (U.S. NIH Grant/Contract); K23CA100691 (NIH); UWCC-6271; UWCC-03-6843-D03; UWCC-117; FHCRC-6271; CDR0000492707 (REGISTRY: PDQ)