Vaccination of High Risk Breast Cancer Patients
Condition: Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG
Intervention description: All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
Intervention MeSH terms: Monatide (IMS 3015)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon
      immunization of breast cancer subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of all races with histologically or cytologically confirmed stage IV
             breast cancer are eligible. The cancer may be newly diagnosed metastatic or relapsed
             after primary or adjunctive therapy and must not have required a treatment change for
             2 months. Treatments with anti-estrogen therapy or chemotherapy are allowed. The
             chemotherapy regimen cannot contain steroids in the pre or post supportive care
             medications. If a subject is on an investigational drug, the drug must be cleared from
             the body over a period of 4 weeks.

          -  Disease staging will be done according to the American Joint Commission on Cancer
             (AJCC), sixth edition.

          -  Age 18 years and older of all races and ethnicity.

          -  ECOG Performance Status 0 or 1.

          -  Subjects must not have an active infection requiring treatment with antibiotics.

          -  Subjects must not have other significant medical, surgical or psychiatric conditions,
             or require any medication or treatment, which may interfere with compliance of the
             treatment regimen.

          -  Subjects must not have a diagnosis or evidence of organic brain syndrome, significant
             impairment of basal cognitive function or any psychiatric disorder that might preclude
             participation in the full protocol.

          -  Subjects must have no other current malignancies. Subjects with prior history at any
             time of any in situ cancer, including lobular carcinoma of the breast in situ,
             cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ
             or basal or squamous skin cancer are eligible, provided they are disease-free at the
             time of registration. Subjects with other malignancies are eligible if they have been
             continuously disease free for ≥ 5 years prior to the time of registration.

          -  Subjects must not have autoimmune disorders or conditions of immunosuppression. This
             includes, but is not limited to being treated with corticosteroids, including oral
             steroids (i.e. prednisone, dexamethasone), continuous use of topical steroid creams or
             ointments or any steroid-containing inhalers. Subjects who have been on systemic
             steroids will require a 6-week washout period. Subjects who discontinue the use of
             these classes of medication for at least 6 weeks prior to registration are eligible
             if, in the judgment of the treating physician, the subject is not likely to require
             these classes of drugs during the treatment period. Replacement doses of steroids for
             subjects with adrenal insufficiency are allowed.

          -  Women of childbearing potential must not be pregnant (negative serum pregnancy test
             must be done 48 hours prior to receiving the first dose of study drug) or
             breastfeeding,due to the unknown effects of peptide/mimotope vaccines on a fetus or
             infant.

          -  Women of childbearing potential must be counseled to use an accepted and effective
             method of contraception (including abstinence) while on treatment and for a period of
             18 months after completing or discontinuing treatment. Accepted methods include oral
             contraceptives, barrier method, Intrauterine Devices (IUDs), and abstinence.

          -  Subjects must have obtained a white blood cell (WBC) count ≥ 3,000/mm3 and platelet
             count ≥ 100,000/mm3 within 2 weeks prior to registration.

          -  Subjects must have a serum glutamic-oxaloacetic transaminase (SGOT)/aspartate
             aminotransferase test (AST) and bilirubin ≤ 2 x institutional upper limit (IUL) of
             normal and serum creatinine ≤ 1.8 mg/dl, all obtained within 2 weeks prior to
             registration.

          -  Subjects must be immunocompetent as measured by responsiveness to two recall antigens
             by skin testing.

          -  All subjects who wish to participate in the study must sign an informed consent
             approved by the UAMS Institutional Review Board (IRB).

          -  Laboratory tests must be completed within 2 weeks before the first dose.