A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.
详细描述
OBJECTIVES:
- Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells.
- Assess time to recurrence in these patients.
OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 advanced malignancy that expresses HER2/neu
- •Stage IIA breast cancer with more than 6 positive lymph nodes
- •Stage IIB, IIIA, or IIIB breast cancer
- •Stage III ovarian cancer
- •Lymph node positive gastric cancer
- •Metastatic tumor
- •No measurable or evaluable disease after standard treatment
- •No previously irradiated or newly diagnosed CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •Greater than 6 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Hemoglobin at least 9 mg/dL
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •No hepatic disease, including viral hepatitis
- •Creatinine less than 2.5 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No asthma or chronic obstructive pulmonary disease
- •Immunologic:
- •Must have positive intradermal delayed hypersensitivity test for at least 1 of the following:
- •Trichophyton
- •Histoplasmin
- •No prior autoimmune disease including, but not limited to, the following:
- •Inflammatory bowel disease
- •Systemic lupus erythematosus
- •Ankylosing spondylitis
- •Scleroderma
- •Multiple sclerosis
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •Hepatitis B surface antigen and hepatitis C antibody negative
- •No other concurrent serious chronic or acute illness or infection (including urinary tract infection)
- •No known shellfish or iodine allergy
- •No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer
- •No medical or psychological condition that may preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- 另有 15 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: 12 months
safety
次要结局
未报告次要终点