Clinical Trials /

Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

NCT03384914

Description:

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
  • Official Title: A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: MCC-19117
  • NCT ID: NCT03384914

Conditions

  • Breast Cancer Female
  • Breast Cancer, Male
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Residual Disease
  • HER2-positive Breast Cancer
  • HER2 Positive Breast Carcinoma

Interventions

DrugSynonymsArms
DC1 VaccineImmunotherapy, Dendritic Cell VaccineDendritic Cell (DC1) Vaccine
WOKVAC VaccineImmunotherapy, pUMVC3-IGFBP2-HER2-IGF1RpUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)

Purpose

The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

Detailed Description

      The total duration of the study will be 6 years (4 years of patient enrollment and 2
      additional years of clinical follow-up). Assessment for disease recurrence and survival will
      be conducted every 6 months (with a phone call/secure email, medical records or follow up
      visit) from the end of treatment for a total of 2 years, until the completion of the trial or
      until documented disease recurrence.
    

Trial Arms

NameTypeDescriptionInterventions
Dendritic Cell (DC1) VaccineActive ComparatorThe vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.
    pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)Active ComparatorThe vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Clinical stage I-III breast cancer with any invasive residual disease in the breast or
                   axillary nodes following neoadjuvant chemotherapy including HER-2 directed treatment.
      
                -  Patients who have received a total of at least 36 weeks of trastuzumab therapy
                   (including neoadjuvant and adjuvant settings).
      
                -  Less than 6 months from the completion of last trastuzumab infusion.
      
                -  Age ≥ 18 years.
      
                -  Eastern Cooperative Group (ECOG) performance status 0 or 1.
      
                -  Must have normal organ and marrow function as defined below within 2 weeks of
                   registration:
      
                     -  Absolute neutrophil count (ANC) ≥ 1,500/ μL
      
                     -  Platelets ≥ 75,000/ μL
      
                     -  Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except
                        patients with Gilbert's syndrome in whom total bilirubin must be <3.0 mg/dL
      
                     -  AST/ALT ≤ 3 x institutional upper limit of normal (ULN)
      
                     -  Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
      
                     -  Hemoglobin A1C <6.5%
      
                -  Left ventricular ejection fraction (LVEF) above institutional lower limit of normal
                   (by echocardiogram or MUGA scan within 90 days of registration).
      
                -  Females of child-bearing potential must agree to use dual methods of contraception and
                   have a negative serum pregnancy test at screening, and males must use an effective
                   barrier method of contraception if sexually active with a female of child-bearing
                   potential. For both male and female participants, effective methods of contraception
                   must be used throughout the study and for three months following the last dose.
      
                -  Ability to understand and willingness to sign a written informed consent document
                   prior to initiation of any screening or study-specific procedures.
      
              Exclusion Criteria:
      
                -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
                   infection, congenital prolonged QT syndrome, symptomatic congestive heart failure,
                   unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
                   that would limit compliance with study requirements.
      
                -  Uncontrolled autoimmune disease requiring active systemic treatment.
      
                -  Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating
                   factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.
      
                -  Pregnant or breast feeding.
      
                -  Known HIV-positive.
      
                -  Known current or a history of hepatitis B or C virus, including chronic and dormant
                   states, unless disease has been treated and confirmed cleared.
      
                -  Major surgery within 4 weeks of initiation of study drug.
      
                -  Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular,
                   intra-articular, intranasal, inhalational corticosteroids (with minimal systemic
                   absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30days
                   prior to starting study drug will be excluded.
      
                -  Potential participant is currently enrolled in any other clinical protocol or
                   investigational trial that involves administration of experimental therapy and/or
                   therapeutic devices, or investigational drug.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Disease-free Survival (DFS)
      Time Frame:Up to 7 years
      Safety Issue:
      Description:Clinical activity is characterized by disease-free survival (DFS), defined as the time from start of treatment to documented recurrence (any breast event), death due to any cause or last patient contact that documents recurrence-free status (i.e., a clinic or scan date).

      Secondary Outcome Measures

      Measure:Immunogenicity
      Time Frame:Up to 7 years
      Safety Issue:
      Description:The primary immunogenicity outcome for both arms of this trial will be the summation of spots (ELISPOT) for 6 distinct peptides and reported as total SFC/10^6 cells. A value >150 defines an immune response.

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

      Trial Keywords

      • axillary nodes
      • HER-2 directed treatment

      Last Updated

      February 12, 2018