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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107211
• Other study ID #: CDR0000416200
• Secondary ID: UPCC-08102UPCC-7
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2005
• Last updated: September 16, 2014
• Start date: January 2005
• Est. completion date: July 2008

Study information

• Verified date: September 2014
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Biological:
• therapeutic autologous dendritic cells

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,