Immunotherapy Vaccine and Herceptin in Breast Cancer

January 6, 2017 updated by: George E. Peoples, Cancer Insight, LLC

Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients

The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following:

  • Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab
  • Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
  • Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age > 18 years
  • HER2/neu+ over-expressing breast cancer (IHC 3+ or FISH ≥2.0)
  • Patients who are receiving adjuvant trastuzumab as standard of care treatment
  • Completion of breast cancer therapy (i.e., surgery, radiation, and chemotherapy as appropriate per standard of care for patients' specific cancer) to exclude trastuzumab (Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.)
  • Enrollment must occur so that patients' trastuzumab treatment and vaccine schedule overlap for all 6 vaccinations and so that first vaccination occurs after a standard of care Multiple Gated Acquisition Scan (MUGA)
  • ECOG performance status (PS) 0-1
  • Clinically cancer-free (no evidence of disease; excluding +CTC)
  • If the patient is of childbearing potential, she must be willing to practice adequate contraception through the study treatment period and for 2 months after completion of the injection sites
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Clinical and/or radiographic evidence of residual or persistent breast cancer
  • Receiving immunosuppressive therapy to include methotrexate or steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed)
  • Tbili >1.8, creatinin >2, hemoglobin <10, platelets <100,000/mm³, WBC <2,000
  • Active pulmonary disease requiring medication to include multiple inhalers
  • Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
  • Pregnant or are nursing
  • History of autoimmune disease (patients with vitiligo not excluded)
  • HIV positive
  • Previous or concomitant malignancies at other sites, except effectively treated non- melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured
  • Other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk
  • Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrollment
  • Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GP2 peptide + GM-CSF + trastuzumab
HLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab
Drug: GP2 peptide + GM-CSF vaccine plus trastuzumab
HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab
Active Comparator: Trastuzumab
HLA-A2-/A3- subjects followed as controls receiving trastuzumab.
Drug: Trastuzumab
HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: 12 months
Patients receiving treatment will be followed from baseline to completion of study for adverse events using CTCAE v4.0
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Insight, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George E Peoples, MD, Cancer Insight

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C.2008.146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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