HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer (Adjuvant)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02063724
First received: February 6, 2014
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

This trial will be determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Subjects will have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without trastuzumab or recurrence exclusive of new primary tumor but rendered NED. 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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Change in Blood Pressure [ Time Frame: 15, 30, 45, & 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 in order to identify and measure any chnge from baseline.

  • Change in Temperature [ Time Frame: 15, 30, 45, & 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 in order to identify and measure any chnge from baseline.

  • Change in Pulse [ Time Frame: 15, 30, 45, & 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 in order to identify and measure any chnge from baseline.


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 2017
Estimated Primary Completion Date: January 2016 (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. Subjects with HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered NED 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 booster vaccines will be administered at 3 month intervals following the initial 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 over Age 18 years.
  • Subjects with Invasive Breast Cancer at least Stage IIIA greater than or equal to N2 (4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative verified by the Department of Pathology at the Hospital of the University of Pennsylvania that have completed chemotherapy and/or trastuzumab and are within 1 year from there last treatment and have no evidence of disease.
  • Patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations
  • 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.
  • Subjects with positive HIV or hepatitis C at baseline by report.
  • Subjects with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec
  • Subjects with major cardiac illness MUGA less than 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: NCT02063724

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
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Brian J Czerniecki, M.D., Ph.D. University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02063724     History of Changes
Obsolete Identifiers: NCT02110173
Other Study ID Numbers: 818532, 25113
Study First Received: February 6, 2014
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Invasive Breast Cancer
Breast Cancer
Immunotherapy
Vaccine
Dendritic Cell

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

ClinicalTrials.gov processed this record on October 29, 2014