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

February 10, 2014
February 11, 2014
January 2014
June 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02061423 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
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.
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.
Intervention: Biological: HER-2 pulsed Dendritic Cell Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
January 2019
June 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Jeanne Kobilnyk, MBE 215-349-8399 jeanne.kobilnyk@uphs.upenn.edu
United States
 
NCT02061423
818561, 26113
Yes
Brian Czerniecki, University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Brian J Czerniecki, MD, PhD University of Pennsylvania
University of Pennsylvania
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP