Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Initial Cohort
Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration 5 doses of 300 micrograms
  • Biological: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG
    All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
Active Comparator
Escalation Cohort
Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 500 micrograms
  • Biological: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG
    All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
Active Comparator
De-escalation Cohort
Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG Subcutaneous administration of 5 doses of 100 micrograms
  • Biological: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG
    All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule

Recruiting Locations

More Details

NCT ID
NCT01390064
Status
Completed
Sponsor
University of Arkansas

Detailed Description

After signing Institutional Review Board (IRB) approved consent, cohorts of 3-6 stage IV breast cancer subjects will be enrolled into the study. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous (SC) injections of the vaccine on 5 separate occasions during Weeks 1, 2, 3, 7, and 19. The first cohort will begin with the 300 mg dose, and then the subsequent cohorts will escalate to 500 mg or de-escalate to 100 mg as determined by the toxicity criteria. The immunization at week 19 is considered a booster immunization. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last for approximately 12 - 24 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.