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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00363012
• Lead Sponsor: University of Washington

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-04
• Disposition First Submitted: 2017-04-03
• Disposition First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Disposition First Posted: 2017-04-05
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein	6 months after active immunization

Secondary Outcome Measures

Name	Time	Method
Characterization of memory T-cell population by intracellular cytokine staining	3, 6, and 12 months after active immunization
Quantitate memory precursor frequency by intracellular cytokine staining	3, 6, and 12 months after active immunization

Trial Locations

Locations (2)

Tumor Vaccine Group at the University of Washington; 🇺🇸 Seattle, Washington, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States