NCT00057915已完成1 期
A Phase I Study of Active Immunotherapy With CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients With Stage IV CEA Expressing Malignancies
Duke University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2003年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.
详细描述
OBJECTIVES:
- Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies.
- Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients.
- Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts.
- Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations.
- Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations.
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 malignancy that is refractory to standard therapy known to have a survival benefit
- •Stage IV disease
- •Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following:
- •Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining
- •Peripheral blood CEA greater than 2.5 mg/dL
- •Tumor known to be universally CEA positive (i.e., colon or rectal cancer)
- •HLA-A201 positive
- •Measurable disease*
- •At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion
- •Received at least 1 prior standard chemotherapy regimen known to have a survival benefit
- •Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g., epoetin alfa] allowed)
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease)
- •SGOT/SGPT less than 1.5 times upper limit of normal
- •No hepatic disease that would preclude study participation
- •No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology
- •Creatinine less than 2.5 mg/dL
- •No urinary tract infection
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •Immunologic
- •No history of autoimmune disease, including any of the following:
- •Inflammatory bowel disease
- •Systemic lupus erythematosus
- •Ankylosing spondylitis
- •Scleroderma
- •Multiple sclerosis
- •No active acute or chronic infection
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other serious chronic or acute illness that would preclude study participation
- •No medical or psychological impediment that would preclude study compliance
- •No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer
- •No allergy to study vaccine components
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior immunotherapy
- •No other concurrent immunotherapy
- 另有 19 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
The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
次要结局
- Immune response(12 weeks)
研究者
Michael Morse, MD
Principal Investigator
Duke University
研究点 (2)
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