NCT00404339已完成1 期
Adjuvant p53 Peptide Loaded DC-Based Therapy for Subjects With Squamous Cell Cancer of the Head and Neck (A Phase I Safety and Immunogenicity Trial)
Robert Ferris1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2005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
- 17
- 试验地点
- 1
- 主要终点
- Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
研究概览
简要总结
RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in treating patients with head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of intranodally injected autologous dendritic cells (DC) loaded with wild-type p53 peptides with or without T-helper peptide epitope in patients with squamous cell carcinoma of the head and neck.
Secondary
- Determine the local and systemic immunomodulatory effects of this vaccine in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the head and neck
- •Resectable disease
- •Any stage allowed
- •Successfully treated with curative intent
- •Recurrent disease allowed provided the following criteria are met:
- •No evidence of disease
- •At least 6 weeks since prior antitumor therapy
- •Positive for HLA-A2.1
- •HLA-DR4 allele status known
- •Tumor tissue must be available
- •No active brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0 or 1
- •Life expectancy ≥ 6 months
- •Granulocyte count > 2,500/mm^3
- •Lymphocyte count > 700/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 0.2 mg/dL
- •Creatinine < 0.2 mg/dL
- •Hemoglobin > 8 g/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after study completion
- •No systemic infection or coagulation disorders
- •No psychiatric disturbances that would preclude obtaining informed consent or safe conduct of protocol
- •HIV negative
- •Hepatitis B surface antigen and hepatitis C antibody negative
- •No other active malignancies
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 6 weeks since prior adjuvant radiotherapy or chemoradiotherapy
- •No time restriction for prior curative therapy
- •No concurrent pharmacological doses of steroids in any form (topical or systemic)
排除标准
- 未提供
结局指标
主要结局
Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
Biologic response rate
Toxicity profile and overall toxicity rates
次要结局
未报告次要终点
研究者
Robert Ferris
UPMC Endowed Professor and Chief, Division of Head and Neck Surgery, Department of Otolaryngology
University of Pittsburgh
研究点 (1)
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