Clinical Trials /

A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

NCT02336984

Description:

The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab. This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.

Related Conditions:
  • Ductal Carcinoma In Situ
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
  • Official Title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS

Clinical Trial IDs

  • ORG STUDY ID: UPCC 03114
  • NCT ID: NCT02336984

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
HER-2 pulsed DC1vaccineCombination Therapy
trastuzumabHerceptinCombination Therapy
pertuzumabPerjetaCombination Therapy

Purpose

The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will assess the safety and immunogenicity of the combination therapy. The target population is women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive. Participants will receive 6 vaccines along with 2 doses of trastuzumab. This study began at the Abramson Cancer Center of the University of Pennsylvania and will continue at H. Lee Moffitt Cancer Center and Research Institute.

Trial Arms

NameTypeDescriptionInterventions
Combination TherapyExperimentalCombination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab.
  • trastuzumab
  • pertuzumab

Eligibility Criteria

        Inclusion Criteria:

          -  Women >= 18 years.

          -  Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not
             had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with
             positive margins.

          -  Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS
             during vaccinations.

          -  Women of childbearing age with a negative pregnancy test documented prior to
             enrollment.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

          -  Women of childbearing potential must agree to use a medically acceptable form of birth
             control during their participation in the study.

          -  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.

          -  Positive for HIV or hepatitis C at baseline by self-report.

          -  Potential participants with coagulopathies, including thrombocytopenia with platelet
             count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec

          -  Major cardiac illness MUGA or ECHO <50% EF.

          -  Pre-existing medical illnesses or medications which might interfere with the study as
             determined by Principal Investigator (PI).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of Related Adverse Events (AEs)
Time Frame:5 years
Safety Issue:
Description:Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • Ductal carcinoma in situ (DCIS)

Last Updated

September 22, 2017