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

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.