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
N/A
Both
Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
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:
No
Principal Investigator
Lupe G. Salazar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tumor Vaccine Group at the University of Washington
Authority:
United States: Food and Drug Administration
Study ID:
6271
NCT ID:
NCT00363012
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
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| Tumor Vaccine Group at the University of Washington | Seattle, Washington 98109 |
