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
  Purpose

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.


Condition Intervention Phase
Estrogen Independent Advanced Breast Cancer
Biological: HER-2 pulsed DC1 vaccine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women with estrogen independent advanced breast cancer Biological: HER-2 pulsed DC1 vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02110199

Contacts
Contact: Brian Czerniecki, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brian Czerniecki, MD, phD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Brian Czerniecki, MD, PhD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Brian Czerniecki, MD, PhD Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02110199     History of Changes
Other Study ID Numbers: UPCC 26113
Study First Received: April 8, 2014
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014