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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT02061423
First received: February 10, 2014
Last updated: June 7, 2016
Last verified: February 2016

February 10, 2014
June 7, 2016
January 2014
February 2016   (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 ]
    Participants 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 participants will have a post-vaccine bilateral mammogram to evaluate response to vaccination. Mammograms will be performed within two weeks after the 6th vaccination.
  • 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.
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 participants with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Participants 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. Participants 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 participants' 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 participant demonstrate no HER-3 or HER-1 response post induction vaccines. Immune analysis will be done after participant receives all induction vaccines and again after they receive all booster vaccines.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.

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.
 
Active, not recruiting
6
June 2018
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ≥ 18 years.
  • 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.
  • 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.
  • Potential participants with MUGA < 50% EF.
  • Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02061423
MCC-18776, 26113
No
Not Provided
Not Provided
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Not Provided
Principal Investigator: Brian Czerniecki, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
February 2016

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