DC Vaccine for Patients With Ductal Carcinoma In Situ

NCT02061332 | Completed Phase 1 DMC

• 2 other identifiers: 80701015107
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; DCIS

Keywords

Breast Cancer; DCIS; Immunotherapy; Vaccine; Dendritic Cell

Outcome Measures

Primary Outcomes (3)

• 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.

  up to 60 minutes post vaccine

• Temperature

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

  up to 60 minutes post vaccine

• Pulse

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

  up to 60 minutes post vaccine

Secondary Outcomes (3)

• Immune Response

  6-8 weeks

• Mammogram

  6-8 weeks

• MRI

  6-8 weeks

Study Arms (3)

Intranodal Vaccine

EXPERIMENTAL

An 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.

Biological: HER-2 Pulsed Dendritic cell Vaccine

Intralesional Vaccine

EXPERIMENTAL

The 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.

Biological: HER-2 Pulsed Dendritic cell Vaccine

Intranodal + Intralesional Vaccine

EXPERIMENTAL

You 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.

Biological: HER-2 Pulsed Dendritic cell Vaccine

Interventions

HER-2 Pulsed Dendritic cell Vaccine BIOLOGICAL

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

Intralesional Vaccine; Intranodal + Intralesional Vaccine; Intranodal Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 17638860 BACKGROUND

• 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.

  PMID: 17293384 BACKGROUND

• 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.

  PMID: 22130160 BACKGROUND

• 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.

  PMID: 22252842 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Brian J Czerniecki, M.D., Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: July 1, 2009
• Primary Completion: August 8, 2014
• Study Completion: October 7, 2015
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

US (1)