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Breast CancerPhase 1/2DCIS6NCT02061332

DC Vaccine for Patients With Ductal Carcinoma In Situ

A Phase 1/2 study testing HER-2 Pulsed Dendritic cell Vaccine in people with Breast Cancer and DCIS, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, DCIS
What is being tested?
HER-2 Pulsed Dendritic cell Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
Jul 2009to 7 Oct 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years.
  • Subjects with biopsy-proven DCIS, DCIS with microinvasion, DCIS with invasive disease under 5 mm, or Paget's Disease of the nipple (DCIS of the nipple) who have not yet received definitive treatment.
  • HER-2/neu positive tumor as determined by >5% of tumor population expressing this marker by immunohistochemical staining 2+ using anti-HER-2/neu verified by Dr. Paul Zhang in the Department of Pathology.
  • Women of childbearing age with a negative pregnancy test documented prior to enrollment.
  • Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
  • 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.

Who cannot join

  • Pregnant or lactating females (pregnancy testing to be performed within 7 days prior to administration of first dose of vaccine).
  • Subjects who have had a complete excisional biopsy of their tumor.
  • Subjects with suspicion of invasive disease > 5mm by MRI performed within 2 months of study recruitment.
  • Screen and exclude subjects with positive HIV or hepatitis C at baseline.
  • Subjects with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec
  • Subjects with major cardiac illness MUGA < 50% EF.
  • Subjects with pre-existing medical illnesses or medications which might interfere with the study.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS

Women who are diagnosed with Her-2/neu over-expressing DCIS will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response.

Read the detailed description

The treatment of patients with DCIS can be individualized and tailored to the type of DCIS and the relative risk of the lesion. HER-2/neu over-expressing DCIS represents a group of patients with significant risk for development of invasive breast cancer. In this proposal we will continue to evaluate the development of type I polarized DC for the treatment of DCIS by evaluating whether further improvements in therapeutic response can be achieved by intratumoral administration of HER-2/neu pulsed DC1 compared with our current intranodal administration. Women who are diagnosed with Her-2/neu over-expressing DCIS with no invasive carcinoma will be eligible for this study. Patients will receive DC1 vaccines by intranodal, intralesional, or both routes of administration. The primary objective will be safety and administration with secondary objectives of immune activation and clinical response. We will also develop a novel assay to monitor ongoing immunity to HER-2/neu, and lastly will begin to develop these vaccines for patients with invasive breast cancer as well. Fifty-four subjects will be randomized to one of three treatment arms: intranodal injection, intralesional injection, or intranodal and intralesional injection of the vaccine. Upon entering this study, the subjects' blood will be drawn in a way that collects only the white blood cells. Subjects then receive six vaccines over a six week period. They will then undergo the standard surgical procedure to remove any remaining DCIS in the breast.

Conditions
Breast Cancer, DCIS
Being tested
HER-2 Pulsed Dendritic cell Vaccine
Keywords
Breast Cancer, DCIS, Immunotherapy, Vaccine, Dendritic Cell
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HER-2 Pulsed Dendritic cell VaccineBiological

    6 weekly HER-2 pulsed dendritic cell vaccines will be administered to subjects in each of the 3 arms.

Study groups in NCT02061332
Study groupRoleWhat they receive
Intranodal VaccineExperimentalAn ultrasound device (probe) will be placed over the area of the groin or armpit. The vaccine needle will then be placed under the probe, and guided by the ultrasound machine to the groin lymph nodes or axillary nodes. You will be given a HER-2 pulsed dendritic cell vaccine in two different groin lymph nodes or axillary nodes per visit. Each dose will consist of 1.0-2.0 x 107 cells and will be injected into 1-2 different groin lymph nodes or axillary nodes.
Receives: Biological: HER-2 Pulsed Dendritic cell Vaccine
Intralesional VaccineExperimentalThe HER-2 pulsed dendritic cell vaccine will be directly injected into the quadrant of the breast affected with DCIS. The location will be determined by referring to the patient's mammogram. Each dose will consist of 1.0-2.0 x 107 cells and will be injected into the quadrant of the breast affected with DCIS.
Receives: Biological: HER-2 Pulsed Dendritic cell Vaccine
Intranodal + Intralesional VaccineExperimentalYou will be given a HER-2 pulsed dendritic cell vaccine in two different groin lymph nodes or axillary nodes and the quadrant of the breast affected with DCIS. An ultrasound device (probe) will be placed over the groin or armpit. The vaccine needle will be placed under the probe, and guided by the ultrasound machine to the groin lymph nodes or axillary nodes. The intralesional vaccine will be directly injected into the quadrant of the breast affected with DCIS. The location will be determined by referring to the patient's mammogram. Each dose will consist of 1.0-2.0 x 107 cells. Approximately half of the dose will be injected into 1-2 different groin lymph nodes or axillary nodes. The remaining half will be injected into the quadrant of the breast affected with DCIS.
Receives: Biological: HER-2 Pulsed Dendritic cell Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Blood pressure will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.

    Measured: up to 60 minutes post vaccine

  2. Temperature

    Temperature will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.

    Measured: up to 60 minutes post vaccine

  3. Pulse

    Pulse will be obtained just prior to the vaccination then, every 15 minutes for the first hour after the dose is given.

    Measured: up to 60 minutes post vaccine

Secondary outcomes (3)

  1. Immune Response

    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.

    Measured: 6-8 weeks

  2. Mammogram

    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.

    Measured: 6-8 weeks

  3. MRI

    All subjects will have a post-vaccine bilateral breast MRI to evaluate response to vaccination. MRIs will be performed within two weeks after the 6th vaccination.

    Measured: 6-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2014 (estimated)
  2. Study startJul 2009
  3. Primary completion8 Aug 2014
  4. Study completion7 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02061332
Sponsor's protocol ID
807010
Other IDs
15107
Acronym
DCIS6
Status last verified
Apr 2020
First submitted
10 Feb 2014
Last updated
10 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Czerniecki BJ, Roses RE, Koski GK. Development of vaccines for high-risk ductal carcinoma in situ of the breast. Cancer Res. 2007 Jul 15;67(14):6531-4. doi: 10.1158/0008-5472.CAN-07-0878.

    PubMed 17638860

  • Czerniecki BJ, Koski GK, Koldovsky U, Xu S, Cohen PA, Mick R, Nisenbaum H, Pasha T, Xu M, Fox KR, Weinstein S, Orel SG, Vonderheide R, Coukos G, DeMichele A, Araujo L, Spitz FR, Rosen M, Levine BL, June C, Zhang PJ. Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. Cancer Res. 2007 Feb 15;67(4):1842-52. doi: 10.1158/0008-5472.CAN-06-4038. Epub 2007 Feb 9.

    PubMed 17293384

  • Koski GK, Koldovsky U, Xu S, Mick R, Sharma A, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Czerniecki BJ. A novel dendritic cell-based immunization approach for the induction of durable Th1-polarized anti-HER-2/neu responses in women with early breast cancer. J Immunother. 2012 Jan;35(1):54-65. doi: 10.1097/CJI.0b013e318235f512.

    PubMed 22130160

  • Sharma A, Koldovsky U, Xu S, Mick R, Roses R, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Koski G, Czerniecki BJ. HER-2 pulsed dendritic cell vaccine can eliminate HER-2 expression and impact ductal carcinoma in situ. Cancer. 2012 Sep 1;118(17):4354-62. doi: 10.1002/cncr.26734. Epub 2012 Jan 17.

    PubMed 22252842

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HER-2 Pulsed Dendritic cell Vaccine in people with Breast Cancer and DCIS, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: up to 60 minutes post vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02061332, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.

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