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

University of Washington

Status: Completed

Conditions: Breast Cancer

Treatments: Other: immunohistochemistry staining method; Other: flow cytometry; Biological: HER-2/neu intracellular domain protein; Other: Sterile water placement; Procedure: biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00363012

FHCRC-6271

UWCC-6271

K23CA100691 (U.S. NIH Grant/Contract)

P30CA015704 (U.S. NIH Grant/Contract)

UWCC-03-6843-D03

UWCC-117

6271

CDR0000492707 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)