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HER2/Neu PositivePhase 1/2NCT00194714

Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab

A Phase 1/2 study testing HER-2/neu Peptide Vaccine and Laboratory Biomarker Analysis in people with HER2/Neu Positive and HLA-A2 Positive Cells Present, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Read more about this study

Who is it for?
Ages 19 years and older, women only
What is being tested?
HER-2/neu Peptide Vaccine and Laboratory Biomarker Analysis
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
May 2016to 22 May 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have either stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy
  • HER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by fluorescence in situ hybridization (FISH)
  • Subjects must be HLA-A2 positive
  • Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and any immunosuppressive agents such as systemic steroids for at least 30 days prior to enrollment; patients should continue trastuzumab monotherapy throughout the course of this protocol; concurrent hormonal and biphosphonate therapies are allowed
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score = 0 or 1
  • Male subjects must agree to contraceptive use during the study period (7 months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
Show all 14Show fewer
  • Hematocrit >= 30 performed within 60 days of enrollment
  • Platelet count >= 100,000 performed within 60 days of enrollment
  • White blood cells (WBC) >= 3000/ul performed within 60 days of enrollment
  • Stable creatinine =< 2.0 mg/dL or creatinine clearance >= 60 ml/min performed within 60 days of enrollment
  • Serum bilirubin < 1.5 mg/dl performed within 60 days of enrollment
  • Serum glutamic-oxaloacetic transaminase (SGOT) < 2 x upper limit of normal (ULN) performed within 60 days of enrollment
  • Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival
  • Patients must have a baseline left ventricular ejection fraction (LVEF) measured by multi-gated acquisition scan (MUGA) equal to or greater than the lower limit of normal for the radiology facility and if there are two consecutive MUGAS performed while on trastuzumab from the same radiology facility, there cannot be a decrease in LVEF of > 15% from the original MUGA scan

Who cannot join

  • Subjects cannot be simultaneously enrolled on other treatment studies
  • Any contraindication to receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) based vaccine products
  • Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
  • Active autoimmune disease
  • Subjects cannot have an active immunodeficiency disorder, e.g. human immunodeficiency virus (HIV)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I/II Study of Combination Immunotherapy for the Generation of HER-2/Neu (HER2) Specific Cytotoxic T Cells (CTL) in Vivo

This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety of administering a HER2 cytotoxic T-cell (CTL) peptide-based vaccine (HER-2/neu peptide vaccine) to stage IV breast and ovarian cancer patients receiving maintenance trastuzumab.

II. To quantify and characterize antigen specific T cell subsets specific to HER2 in peripheral blood mononuclear cell (PBMC) of patients after vaccination with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.

SECONDARY OBJECTIVES:

  1. To evaluate overall survival (OS) in patients who complete a vaccination series with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.

OUTLINE:

Patients receive HER-2/neu peptide vaccine intradermally (ID) once per month for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then yearly for up to 5 years.

Being tested
HER-2/neu Peptide Vaccine, Laboratory Biomarker Analysis
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HER-2/neu Peptide VaccineBiological

    Also called HER-2-Neu Peptide Vaccine, HER-2/neu Helper-Peptide Vaccine

    Given ID

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00194714
Study groupRoleWhat they receive
Treatment (HER-2/neu peptide vaccine)ExperimentalPatients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.
Receives: Biological: HER-2/neu Peptide Vaccine; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis

    ELIspot: Increased immune response is defined as spots per well (SPW) greater than 2 standard deviations (SD) above baseline value, remained the same if the mean SPW was within 2 SD of the previous value, or decreased if the mean SPW was greater than 2 SD below the previous value. Two SD is equivalent to a P value of .05 in that there is a 95% probability that the values are statistically significant. T is reported as percentage of patients and their corresponding results.

    HLA-A2 Major Histocompatibility Complex Tetramer Analysis is evaluated using a non-radioactive assay for cell lysis. The HLA-A2 transfected human HER2/neu expressing breast cancer cell line, SKBR3-A2 T cells, expanded after stimulation with immunizing peptide, were added in an effector/target ratio of 40:1. Percent specific lysis was calculated as: ([experimental release-spontaneous releases of cytotoxic T-lymphocyte cells and target cells]/[maximum release-spontaneous release of target cells])X100.

    Measured: Up to 1.5 years (12 months following the last vaccination)

  2. Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0

    Descriptive statistics will be used to summarize changes from baseline. At the point the participant signs consent and before they start vaccine we record their existing baseline events (symptoms and diagnoses) and assign a grade to them (see below). Once a participant starts vaccine treatment adverse event AEs were recorded if they are new to the participant or if they increased in severity over their baseline.

    Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

    Measured: Up to 7 months (30 days following the last vaccination)

Secondary outcomes (1)

  1. Overall Survival

    Survival for the Stage IV breast cancer patients will be compared to historical control.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startMay 2016
  3. Primary completion31 Mar 2021
  4. Study completion22 May 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00194714
Sponsor's protocol ID
6304
Other IDs
NCI-2016-00895, 6304, P30CA015704, RG1000607
Status last verified
May 2024
First submitted
13 Sep 2005
Last updated
6 Jun 2024
Data monitoring committee
No

Publications

  • Disis ML, Wallace DR, Gooley TA, Dang Y, Slota M, Lu H, Coveler AL, Childs JS, Higgins DM, Fintak PA, dela Rosa C, Tietje K, Link J, Waisman J, Salazar LG. Concurrent trastuzumab and HER2/neu-specific vaccination in patients with metastatic breast cancer. J Clin Oncol. 2009 Oct 1;27(28):4685-92. doi: 10.1200/JCO.2008.20.6789. Epub 2009 Aug 31.

    PubMed 19720923

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HER-2/neu Peptide Vaccine and Laboratory Biomarker Analysis in people with HER2/Neu Positive and HLA-A2 Positive Cells Present, run by University of Washington at 1 site 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?

The sponsor lists 14 inclusion and 5 exclusion criteria. 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis (time frame: Up to 1.5 years (12 months following the last vaccination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00194714, which also lists 1 linked publication.

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 6 Jun 2024.

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