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 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:
NCT02110199
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 NCT02110199 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 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.

Not Provided
Interventional
Phase 1
Primary Purpose: Treatment
Estrogen Independent Advanced Breast Cancer
Biological: HER-2 pulsed DC1 vaccine
Experimental: Women with estrogen independent advanced breast cancer
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 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.
  • Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  • Subjects with ECOG Performance Status Score of 0 or 1. 5. 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 (pregnancy testing to be performed within 7 days prior to administration of first dose of vaccine).
  • Subjects with positive HIV or hepatitis C at baseline by selfreport.
  • Subjects with coagulopathies, including thrombocytopenia with platelet count 75,000, INR 1.5 and partial thromboplastin time 50 sec
  • Subjects with major cardiac illness or MUGA 50% EF.
  • Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by PI.
  • Subjects with laboratory tests reflecting ¬ grade 1 toxicity by NCI CTC version 3.0 including CBC, liver function tests, urinalysis, EKG if cannot be corrected on repeat test in 7 days.
Female
18 Years and older
No
Contact: Brian Czerniecki, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT02110199
UPCC 26113
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