Clinical trial NCT00107211: Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
Official title: A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
breast cancer in situ
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Brian J. Czerniecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: