Clinical Trials /

Vaccination of High Risk Breast Cancer Patients

NCT02229084

Description:

The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer. This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive breast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Enrolling by invitation

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vaccination of High Risk Breast Cancer Patients
  • Official Title: A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: 202556
  • NCT ID: NCT02229084

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
ChemovaxP10s-PADRE with standard chemotherapy, P10s-PADRE with MONTANIDE™ ISA 51 VG, P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapyChemovax Schedule A

Purpose

The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive breast cancer. This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive breast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive breast cancer.

Trial Arms

NameTypeDescriptionInterventions
Chemovax Schedule AActive ComparatorChemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
    Chemovax Schedule BActive ComparatorChemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
      Chemovax Schedule CActive ComparatorChemovax Schedule C: Subjects will receive three weekly injections of vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
        Chemovax Schedule DActive ComparatorChemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
          Chemovax Schedule EActive ComparatorChemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).

            Eligibility Criteria

                    Inclusion Criteria:
            
                      -  Females of all races with clinical stage I, II, or III ER-positive breast cancer who
                         qualify for standard neoadjuvant treatment
            
                      -  Age 18 years and older
            
                      -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
            
                      -  White blood cell (WBC) count ≥ 3,000/mm3 within 2 weeks prior to registration.
            
                      -  Platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
            
                      -  Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL)
                         of normal obtained within 2 weeks prior to registration.
            
                      -  Aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal
                         obtained within 2 weeks prior to registration.
            
                      -  Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks
                         prior to registration.
            
                      -  Serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
            
                      -  Must sign an informed consent approved by the University of Arkansas for Medical
                         Sciences (UAMS) Institutional Review Board (IRB).
            
                    Exclusion Criteria:
            
                      -  Active infection requiring treatment with antibiotics.
            
                      -  Diagnosis or evidence of organic brain syndrome that might preclude participation in
                         the full protocol.
            
                      -  Diagnosis or evidence of significant impairment of basal cognitive function that might
                         preclude participation in the full protocol.
            
                      -  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.
            
                      -  Autoimmune disorders or conditions of immunosuppression. This includes, but is not
                         limited to being treated with corticosteroids, including oral steroids (i.e.
                         prednisone, dexamethasone [except when used as an antiemetic in standard therapy]),
                         continuous use of topical steroid creams or ointments or any steroid-containing
                         inhalers. 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.
            
                      -  Pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines
                         on a fetus or infant). Women of childbearing potential must have a negative urine
                         pregnancy test within 72 hours prior to receiving the first dose of study drug and
                         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 of contraception include oral
                         contraceptives, barrier methods, Intrauterine Device (IUDs), and abstinence.
            
                      -  Any other significant medical or psychiatric conditions which, in the opinion of the
                         enrolling investigator, may interfere with consent or compliance of the treatment
                         regimen.
                  
            Maximum Eligible Age:N/A
            Minimum Eligible Age:18 Years
            Eligible Gender:Female
            Healthy Volunteers:No

            Primary Outcome Measures

            Measure:Number of participants with sufficiently high anti-P10s immunoglobulin-G response
            Time Frame:Week 64 +/- 4 weeks per subject
            Safety Issue:
            Description:

            Details

            Phase:Phase 1/Phase 2
            Primary Purpose:Interventional
            Overall Status:Enrolling by invitation
            Lead Sponsor:University of Arkansas

            Last Updated

            January 31, 2018