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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363012
• Other study ID #: 6271
• Secondary ID: P30CA015704K23CA
• Status: Completed
• Phase: N/A
• First received: August 10, 2006
• Last updated: April 3, 2017
• Start date: April 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• HER-2/neu intracellular domain protein
300mcg (100mcg/peptide) of the HER2 ICD peptide mixture per skin test. This will be injected intradermally on the back at 6 months post active immunization.

Other:
• flow cytometry
This is a laboratory test used to assess the antigen specific T cell population.
• immunohistochemistry staining method
This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.

Procedure:
• biopsy
A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.

Other:
• Sterile water placement
100mcg of sterile water will be administered intradermally on the back and serves as a negative control for the laboratory analysis. This will be injected intradermally on the back at 6 months post active immunization.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington
United States	Tumor Vaccine Group at the University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunologic memory response to HER-2/neu (HER2) intracellular domain protein		6 months after active immunization
Secondary	Characterization of memory T-cell population by intracellular cytokine staining		3, 6, and 12 months after active immunization
Secondary	Quantitate memory precursor frequency by intracellular cytokine staining		3, 6, and 12 months after active immunization