Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: therapeutic autologous dendritic cells Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Principal Investigator: | Brian J. Czerniecki, MD, PhD | Abramson Cancer Center of the University of Pennsylvania |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00107211 History of Changes |
| Other Study ID Numbers: | CDR0000416200, UPCC-08102, UPCC-704447 |
| Study First Received: | April 5, 2005 |
| Last Updated: | May 14, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
ductal breast carcinoma in situ breast cancer in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 16, 2013