Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vaccination of High Risk Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: June 29, 2011
Last updated: December 17, 2014
Last verified: December 2014

June 29, 2011
December 17, 2014
July 2011
February 2015   (final data collection date for primary outcome measure)
Number of Participants with Adverse Events [ Time Frame: 9 weeks per subject ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01390064 on Archive Site
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Vaccination of High Risk Breast Cancer Patients
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Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon immunization of breast cancer subjects.

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 300mg dose, and then the subsequent cohorts will escalate to 500mg or de-escalate to 100mg 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.

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Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage IV Breast Cancer
Biological: Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG

After signing the IRB-approved informed consent form, research participants will be assigned to a cohort at the time of registration by a clinical research associate (CRA) in the Clinical Research and Data Management (CRDM) office in the Cancer Institute. All research participants will receive the Mimotope P10s-PADRE/MONTANIDETM ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule.

The decision to escalate or de-escalate the dose, expand the cohort or terminate the study will be based on assessment for DLT, which will require 9 weeks per subject. The time to assess a cohort of 3 for DLTs and immune responses is thus anticipated to be 13 weeks based on an accrual rate of 2 eligible Stage IV subjects per month.

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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
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February 2015   (final data collection date for primary outcome measure)

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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
University of Arkansas
University of Arkansas
Department of Defense
Principal Investigator: Laura Hutchins, MD University of Arkansas
University of Arkansas
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP