Breast CancerNCT00363012
Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2
A study testing HER-2/neu intracellular domain protein, flow cytometry and immunohistochemistry staining method in people with Breast Cancer, run by University of Washington at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HER-2/neu intracellular domain protein, flow cytometry and immunohistochemistry staining method
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109-1024
Tumor Vaccine Group at the University of Washington
Seattle, Washington, 98109
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- HER-2/neu intracellular domain protein, flow cytometry, immunohistochemistry staining method, biopsy, Sterile water placement
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2/neu intracellular domain proteinBiological
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.
flow cytometryOther
This is a laboratory test used to assess the antigen specific T cell population.
immunohistochemistry staining methodOther
This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.
biopsyProcedure or surgery
A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.
Sterile water placementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein
Measured: 6 months after active immunization
Secondary outcomes (2)
Characterization of memory T-cell population by intracellular cytokine staining
Measured: 3, 6, and 12 months after active immunization
Quantitate memory precursor frequency by intracellular cytokine staining
Measured: 3, 6, and 12 months after active immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startApr 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary (Nora) Disis, University of Washington
- Investigators
- Lupe G. Salazar, MD, Principal investigator, Tumor Vaccine Group at the University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363012
- Sponsor's protocol ID
- 6271
- Other IDs
- P30CA015704, K23CA100691, UWCC-6271, UWCC-03-6843-D03, UWCC-117, FHCRC-6271, CDR0000492707
- Status last verified
- Apr 2017
- First submitted
- 10 Aug 2006
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00363012
- Acronym / sponsor ID
- 6271
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, male breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER-2/neu intracellular domain protein300mcg (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. | Biological | – |
| flow cytometryThis is a laboratory test used to assess the antigen specific T cell population. | Other | – |
| immunohistochemistry staining methodThis is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy. | Other | – |
| biopsyA 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining. | Procedure or surgery | – |
| Sterile water placement100mcg 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. | Other | – |
Primary outcome
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein
Time frame: 6 months after active immunization
2 secondary outcomes
Characterization of memory T-cell population by intracellular cytokine staining
Time frame: 3, 6, and 12 months after active immunization
Quantitate memory precursor frequency by intracellular cytokine staining
Time frame: 3, 6, and 12 months after active immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lupe G. Salazar, MD principal investigator
Tumor Vaccine Group at the University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HER-2/neu intracellular domain protein, flow cytometry and immunohistochemistry staining method in people with Breast Cancer, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunologic memory response to HER-2/neu (HER2) intracellular domain protein (time frame: 6 months after active immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.