Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer
Condition: Breast Ductal Carcinoma In Situ
MeSH terms: Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
Intervention: Laboratory Biomarker Analysis; Nelipepimut-S Plus GM-CSF Vaccine; Sargramostim; Surgical Procedure
Intervention description: Correlative studies; Given ID; Given ID; Undergo surgery
Intervention MeSH terms: Molgramostim; Vaccines; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or
      sargramostim works in treating patients with breast cancer. Vaccines made from peptide or
      antigen and/or a person's white blood cells mixed with tumor proteins may help the body build
      an effective immune response to kill tumor cells that express breast cancer antigens. It is
      not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in
      treating patients with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be pre- or post-menopausal

          -  Participants must have a diagnosis of DCIS made by core needle biopsy

          -  Participants must be human leukocyte antigen (HLA)-A2 positive

          -  Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1 (Karnofsky
             >= 60%)

          -  Clinical chemistry less than 2 x normal upper limit of normal range

          -  Platelets >= 100,000/mm^3

          -  Hemoglobin >= 10 g/dL

          -  Blood urea nitrogen < 2 x upper limit of normal (ULN)

          -  Alkaline phosphatase < 2 x ULN

          -  Lactate dehydrogenase < 2 x ULN

          -  Creatinine < 2 x ULN

          -  Bilirubin < 2 x ULN

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             < 2 x ULN

          -  A normal ejection fraction, as defined by the participant's institution; only limited
             echocardiograms (ECHOs) will be used as cardiac evaluation; no other tests are
             allowed; ECHO is to be done only in HLA-A2 positive participants; if ECHO has been
             done within 30 days prior to randomization and results showing a normal ejection
             fraction have been obtained prior to randomization, an additional ECHO is not needed
             at baseline

          -  Willingness to comply with all study interventions and follow-up procedures

          -  The ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Invasive breast cancer; areas of microinvasion or suspicious for microinvasion on the
             core biopsy is allowed

          -  History of prior breast cancer treated within the past two years; patients completing
             all breast cancer-specific treatment over two years prior to the current diagnosis are
             eligible

          -  History of prior ductal carcinoma in situ (DCIS) treated within the past two years;
             patients completing all treatment for a previous diagnosis of DCIS over two years
             prior to the current diagnosis are eligible

          -  Prior lobular carcinoma in situ (LCIS) is allowed

          -  Pregnant, unwilling to use adequate contraception during study treatment duration or
             breastfeeding; the effects of NeuVax on the developing human fetus are unknown; for
             this reason and because NeuVax may be teratogenic, pregnant women will be excluded;
             all heterosexually active women who may become pregnant must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation OR be post-menopausal defined as any
             one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year
             in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in
             women with a prior history of chemotherapy exposure who were pre-menopausal prior to
             chemotherapy; should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her study physician immediately

          -  Any autoimmune disease or other medical condition that, in the opinion of the
             investigator, would compromise the subject's safety

          -  Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive
             therapy that might interfere with appropriate immune response

          -  Known history of or known active infection with human immunodeficiency virus (HIV),
             hepatitis B or hepatitis C

          -  Patients on chronic steroid therapy or other immunosuppressive therapy except for
             topical or inhaled steroids known to have low systemic absorption

          -  Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any
             component of the GM-CSF product (e.g., mannitol)

          -  Concurrent treatment with other investigational agent

          -  History of non-breast malignancy within 5 years prior to randomization, except
             curatively treated superficial bladder cancer, carcinoma in situ of the cervix (stage
             0-1), and basal cell or squamous cell carcinoma of the skin

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to NeuVax

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  No recent or planned immunotherapy