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

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:
NCT02063724
First received: February 6, 2014
Last updated: June 7, 2016
Last verified: June 2016

February 6, 2014
June 7, 2016
January 2014
February 2016   (final data collection date for primary outcome measure)
  • 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 change 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.
  • 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.
Complete list of historical versions of study NCT02063724 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
Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants 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.

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 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 participants' 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 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
11
June 2018
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women over Age 18 years.
  • Potential participants 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.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
  • Willing to use birth control if necessary.
  • 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 positive HIV or hepatitis C at baseline by report.
  • Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
  • Major cardiac illness MUGA less than 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
 
NCT02063724
MCC-18777, 25113
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
June 2016

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