Immunotherapy Vaccine and Herceptin in Breast Cancer

Cancer Insight

Status and phase

Completed

Phase 1

Conditions

Breastcancer

Treatments

Drug: GP2 peptide + GM-CSF vaccine plus trastuzumab

Drug: Trastuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03014076

C.2008.146

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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