Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast

September 16, 2014 updated by: Abramson Cancer Center of the University of Pennsylvania

A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

RATIONALE: Vaccines made from peptides and a person's white blood cells may help the body build an effective immune response to kill tumor cells. Injecting the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. Giving vaccine therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast.

PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES:

Primary

  • Determine the feasibility and safety of neoadjuvant ultrasound-guided intranodal vaccine therapy comprising autologous dendritic cells pulsed with recombinant HER2/neu peptides in patients with ductal carcinoma in situ of the breast.
  • Determine the sensitization of CD4+ and CD8+ T cells to HER2/neu in patients treated with this vaccine.
  • Determine clinical response in patients treated with this vaccine.

Secondary

  • Correlate post-vaccine sensitization of CD4+ and CD8+ T cells to HER2/neu with clinical response in patients treated with this vaccine.

OUTLINE: This is a pilot study.

Patients undergo leukapheresis over 2-3 hours to obtain lymphocytes and monocytes. Monocytes are cultured with sargramostim (GM-CSF), interleukin-4, interferon gamma, and lipopolysaccharides for the production of dendritic cells (DC). DC are then pulsed with recombinant HER2/neu peptides to produce the dendritic cell vaccine. Approximately 2 days after leukapheresis, patients receive the vaccine intranodally (into 2 different lymph nodes) by ultrasound guidance once a week for 4 weeks in the absence of unacceptable toxicity. Patients then undergo a second leukapheresis to obtain T lymphocytes for immunologic analysis. Within 2-3 weeks after completion of vaccine therapy, patients undergo lumpectomy or mastectomy AND sentinel lymph node biopsy.

After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR DCIS with microinvasion (< 1 mm) by core biopsy or excisional biopsy
  • HER2/neu positive tumor, defined as > 10% of the tumor population expressing HER2/neu by immunohistochemical staining
  • No evidence of invasive disease by MRI (performed within the past month)

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Over 18

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • No thrombocytopenia (i.e., platelet count < 75,000/mm^3)
  • No other coagulopathy

Hepatic

  • No hepatitis C positivity
  • INR > 1.5
  • PTT > 50 sec

Renal

  • Not specified

Cardiovascular

  • Ejection fraction ≥ 50% by MUGA or echocardiogram
  • No major cardiac illness

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No toxicity > grade 1
  • No other pre-existing medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior ipsilateral breast or axillary radiotherapy

Surgery

  • No prior ipsilateral axillary dissection
  • No prior complete excisional biopsy for DCIS

Other

  • No other prior definitive treatment for DCIS
  • No concurrent medications that would preclude study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center of the University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian J. Czerniecki, MD, PhD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDR0000416200
  • UPCC-08102
  • UPCC-704447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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