HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Brian Czerniecki, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02061423
First received: February 10, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This trial will determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Subjects will have estrogen independent stage I III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.


Condition Intervention Phase
Breast Cancer
Biological: HER-2 pulsed Dendritic Cell Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: up to 60 minutes post vaccine ] [ Designated as safety issue: Yes ]
    Blood pressure will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.

  • Temperature [ Time Frame: up to 60 minutes post vaccine ] [ Designated as safety issue: Yes ]
    Temperature will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.

  • Pulse [ Time Frame: up to 60 minutes post vaccine ] [ Designated as safety issue: Yes ]
    Pulse will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.


Secondary Outcome Measures:
  • Immune Response [ Time Frame: 6-8 weeks, 1 year ] [ Designated as safety issue: No ]
    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.

  • Mammogram [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HER-2 Pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 107 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
Biological: HER-2 pulsed Dendritic Cell Vaccine
6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 107 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.

Detailed Description:

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. 2. Subjects with estrogen independent (as determined by lack of estrogen receptor expression on primary or residual tumor) stage I III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be manufactured using subjects leukapheresis product, which will be administered in the Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three to six booster vaccines will be administered following the initial induction vaccines, should the subject demonstrate no HER-3 or HER-1 response post induction vaccines. Immune analysis will be done after subject receives all induction vaccines and again after they receive all booster vaccines.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ≥ 18 years.
  • Subjects with HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
  • Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
  • Subjects with ECOG Performance Status Score of 0 or 1.
  • Women of childbearing potential must agree to use a medically acceptable form of birth control (medically accepted methods: birth control pills, condoms and spermicidal lubricants, intrauterine device, and diaphragm) during their participation in the study.
  • 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.
  • Subjects with positive HIV or hepatitis C at baseline by self report.
  • Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
  • Subjects with MUGA < 50% EF.
  • Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061423

Contacts
Contact: Jeanne Kobilnyk, MBE 215-349-8399 jeanne.kobilnyk@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jeanne Kobilnyk, MBE    215-349-8399    jeanne.kobilnyk@uphs.upenn.edu   
Principal Investigator: Brian J Czerniecki, MD, PhD         
Sub-Investigator: Angela DeMichele, MD, MSCE         
Sub-Investigator: Robert Roses, MD         
Sub-Investigator: Carla Fisher, MD         
Sub-Investigator: Kevin Fox, MD         
Sub-Investigator: Susan Domchek, MD         
Sub-Investigator: Keerthi Gogineni, MD         
Sub-Investigator: Bonnie Ky, MD, MSCE         
Sub-Investigator: Susan Weinstein, MD         
Sub-Investigator: Paul Zhang, MD, PhD         
Sub-Investigator: Rosemarie Mick, MS         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Brian J Czerniecki, MD, PhD University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Brian Czerniecki, Harrington/Rhoades Professor of Surgery, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02061423     History of Changes
Obsolete Identifiers: NCT02110199
Other Study ID Numbers: 818561, 26113
Study First Received: February 10, 2014
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Invasive Breast Cancer
Breast Cancer
Immunotherapy
Vaccine
Dendritic Cell
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014