Pilot Phase I HER-2 Pulsed DC Vaccine To Prevent Recurrence For Patients With HER-2 Driven High Risk Invasive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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:
NCT02110173
First received: April 8, 2014
Last updated: April 9, 2014
Last verified: April 2014

April 8, 2014
April 9, 2014
February 2014
February 2016   (final data collection date for primary outcome measure)
Number of Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02110173 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Phase I HER-2 Pulsed DC Vaccine To Prevent Recurrence For Patients With HER-2 Driven High Risk 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

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 b0ut rendered NED. Mammogram, laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine administration.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Breast Cancer
Biological: HER-2 pulsed DC1 vaccine
Experimental: women with HER-2 driven IBC at least Stage IIIA
Intervention: Biological: HER-2 pulsed DC1 vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women over Age 18 years.
  • Subjects with Invasive Breast Cancer at least Stage IIIA 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. 3. Patients deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations 4. Women of childbearing age with a negative pregnancy test documented prior to enrollment. 5. Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D). 6. Subjects willing to use birth control if necessary 7. Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Key exclusion criteria

1. Pregnant or lactating females. 2. Subjects with positive HIV or hepatitis C at baseline by report. 3.

Subjects with coagulopathies, including thrombocytopenia with platelet count 75,000, INR 1.5 and partial thromboplastin time 50 sec 4. Subjects with major cardiac illness MUGA 50% EF. 5. 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: Brian Czerniecki, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT02110173
UPCC 25113
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Brian Czerniecki, MD, PhD Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
April 2014

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