Clinical Trials /

DC Vaccine for Patients With Ductal Carcinoma In Situ

NCT02061332

Description:

Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response.

Related Conditions:
  • Ductal Carcinoma In Situ
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: DC Vaccine for Patients With Ductal Carcinoma In Situ
  • Official Title: A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

Clinical Trial IDs

  • ORG STUDY ID: 807010
  • SECONDARY ID: 15107
  • NCT ID: NCT02061332
  • NCT ALIAS: NCT00923143

Conditions

  • Breast Cancer
  • DCIS

Interventions

DrugSynonymsArms
HER-2 Pulsed Dendritic cell VaccineIntranodal Vaccine

Purpose

Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response.

Detailed Description

      The treatment of patients with DCIS can be individualized and tailored to the type of DCIS
      and the relative risk of the lesion. HER-2/neu over-expressing DCIS represents a group of
      patients with significant risk for development of invasive breast cancer. In this proposal we
      will continue to evaluate the development of type I polarized DC for the treatment of DCIS by
      evaluating whether further improvements in therapeutic response can be achieved by
      intratumoral administration of HER-2/neu pulsed DC1 compared with our current intranodal
      administration. Women who are diagnosed with Her-2/neu over-expressing DCIS with no invasive
      carcinoma will be eligible for this study. Patients will receive DC1 vaccines by intranodal,
      intralesional, or both routes of administration. The primary objective will be safety and
      administration with secondary objectives of immune activation and clinical response. We will
      also develop a novel assay to monitor ongoing immunity to HER-2/neu, and lastly will begin to
      develop these vaccines for patients with invasive breast cancer as well. Fifty-four subjects
      will be randomized to one of three treatment arms: intranodal injection, intralesional
      injection, or intranodal and intralesional injection of the vaccine. Upon entering this
      study, the subjects' blood will be drawn in a way that collects only the white blood cells.
      Subjects then receive six vaccines over a six week period. They will then undergo the
      standard surgical procedure to remove any remaining DCIS in the breast.
    

Trial Arms

NameTypeDescriptionInterventions
Intranodal VaccineExperimentalAn ultrasound device (probe) will be placed over the area of the groin or armpit. The vaccine needle will then be placed under the probe, and guided by the ultrasound machine to the groin lymph nodes or axillary nodes. You will be given a HER-2 pulsed dendritic cell vaccine in two different groin lymph nodes or axillary nodes per visit. Each dose will consist of 1.0-2.0 x 107 cells and will be injected into 1-2 different groin lymph nodes or axillary nodes.
    Intralesional VaccineExperimentalThe HER-2 pulsed dendritic cell vaccine will be directly injected into the quadrant of the breast affected with DCIS. The location will be determined by referring to the patient's mammogram. Each dose will consist of 1.0-2.0 x 107 cells and will be injected into the quadrant of the breast affected with DCIS.
      Intranodal + Intralesional VaccineExperimentalYou will be given a HER-2 pulsed dendritic cell vaccine in two different groin lymph nodes or axillary nodes and the quadrant of the breast affected with DCIS. An ultrasound device (probe) will be placed over the groin or armpit. The vaccine needle will be placed under the probe, and guided by the ultrasound machine to the groin lymph nodes or axillary nodes. The intralesional vaccine will be directly injected into the quadrant of the breast affected with DCIS. The location will be determined by referring to the patient's mammogram. Each dose will consist of 1.0-2.0 x 107 cells. Approximately half of the dose will be injected into 1-2 different groin lymph nodes or axillary nodes. The remaining half will be injected into the quadrant of the breast affected with DCIS.

        Eligibility Criteria

                Inclusion Criteria:
        
                  -  Age > 18 years.
        
                  -  Subjects with biopsy-proven DCIS, DCIS with microinvasion, DCIS with invasive disease
                     under 5 mm, or Paget's Disease of the nipple (DCIS of the nipple) who have not yet
                     received definitive treatment.
        
                  -  HER-2/neu positive tumor as determined by >5% of tumor population expressing this
                     marker by immunohistochemical staining 2+ using anti-HER-2/neu verified by Dr. Paul
                     Zhang in the Department of Pathology.
        
                  -  Women of childbearing age with a negative pregnancy test documented prior to
                     enrollment.
        
                  -  Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
        
                  -  Subjects willing to use birth control if necessary
        
                  -  Subjects who have voluntarily signed a written Informed Consent in accordance with
                     institutional policies after its contents have been fully explained to them.
        
                Exclusion Criteria:
        
                  -  Pregnant or lactating females (pregnancy testing to be performed within 7 days prior
                     to administration of first dose of vaccine).
        
                  -  Subjects who have had a complete excisional biopsy of their tumor.
        
                  -  Subjects with suspicion of invasive disease > 5mm by MRI performed within 2 months of
                     study recruitment.
        
                  -  Screen and exclude subjects with positive HIV or hepatitis C at baseline.
        
                  -  Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000,
                     INR > 1.5 and partial thromboplastin time > 50 sec
        
                  -  Subjects with major cardiac illness MUGA < 50% EF.
        
                  -  Subjects with pre-existing medical illnesses or medications which might interfere with
                     the study.
        
                  -  Subjects with laboratory tests reflecting ¬> grade 1 toxicity by NCI CTC version 3.0
                     including CBC, liver function tests, urinalysis, EKG if cannot be corrected on repeat
                     test in 7 days.
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:Female
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Blood Pressure
        Time Frame:up to 60 minutes post vaccine
        Safety Issue:
        Description:Blood pressure will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.

        Secondary Outcome Measures

        Measure:Immune Response
        Time Frame:6-8 weeks
        Safety Issue:
        Description:Subjects will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing.
        Measure:Mammogram
        Time Frame:6-8 weeks
        Safety Issue:
        Description:All subjects will have a post-vaccine bilateral mammogram to evaluate response to vaccination. Mammograms will be performed within two weeks after the 6th vaccination.
        Measure:MRI
        Time Frame:6-8 weeks
        Safety Issue:
        Description:All subjects will have a post-vaccine bilateral breast MRI to evaluate response to vaccination. MRIs will be performed within two weeks after the 6th vaccination.

        Details

        Phase:Phase 1/Phase 2
        Primary Purpose:Interventional
        Overall Status:Active, not recruiting
        Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

        Trial Keywords

        • Breast Cancer
        • DCIS
        • Immunotherapy
        • Vaccine
        • Dendritic Cell

        Last Updated

        September 29, 2017