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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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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


- Male or female (male patients are not excluded)

- Menopausal status not specified

- Zubrod performance status 0

- Unable to bear children (female patients)


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Immunologic memory response to HER-2/neu (HER2) intracellular domain protein

Outcome Time Frame:

6 months after active immunization

Safety Issue:


Principal Investigator

Lupe G. Salazar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tumor Vaccine Group at the University of Washington


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • male breast cancer
  • Breast Neoplasms



Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Tumor Vaccine Group at the University of WashingtonSeattle, Washington  98109