Trial | NCT03014076  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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 Started
Jan 31
2008
Primary Completion
Jan 31
2016
Study Completion
Jan 31
2017
Last Update
Jan 09
2017
Estimate

Drug GP2 peptide + GM-CSF vaccine plus trastuzumab

HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab

Drug Trastuzumab

HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.

  • Other names: Herceptin

GP2 peptide + GM-CSF + trastuzumab Experimental

HLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab

Trastuzumab Active Comparator

HLA-A2-/A3- subjects followed as controls receiving trastuzumab.

Criteria 

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
No Results Posted