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Phase 1
18 Years
Open (Enrolling)
Stage IV Breast Cancer

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Trial Information

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

- 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, 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events

Outcome Description:

The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity.

Outcome Time Frame:

9 weeks per subject

Safety Issue:


Principal Investigator

Laura Hutchins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

Related Keywords:

  • Stage IV Breast Cancer
  • Breast Neoplasms



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205