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

April 3, 2017 updated by: Mary (Nora) Disis, University of Washington

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

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)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: 6 months after active immunization	6 months after active immunization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)