NCT00107211已完成1 期
A HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Not specified
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No thrombocytopenia (i.e., platelet count < 75,000/mm^3)
- •No other coagulopathy
- •No hepatitis C positivity
- •INR > 1.5
- •PTT > 50 sec
- •Not specified
- •Cardiovascular
- •Ejection fraction ≥ 50% by MUGA or echocardiogram
- •No major cardiac illness
- •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
- •No prior ipsilateral axillary dissection
- •No prior complete excisional biopsy for DCIS
- •No other prior definitive treatment for DCIS
- •No concurrent medications that would preclude study participation
排除标准
- 未提供
研究者
研究点 (1)
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