Vaccine Therapy in Treating Patients With Head and Neck Cancer
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)
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.
研究概览
详细说明
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.
OUTLINE: This is a randomized, pilot study.
Patients undergo leukapheresis. The resulting dendritic cells (DC) are pulsed with wild-type (wt) p53 peptides with or without T-helper (Th) peptides. Individual autologous vaccines are prepared for each patient. Patients who are HLA-A2-DR4-negative are randomized to 1 of 2 treatment arms (arm I or arm II). Patients who are HLA-A2-DR4-positive are assigned to arm III.
- Arm I: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides only.
- Arm II: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides and Th tetanus toxoid peptide.
- Arm III (HLA-A2-DR4-positive patients only): Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides and Th wt p53 peptide.
In all arms, each vaccine is administered by ultrasonography-guided inguinal intranodal injection over 30 minutes on days 0, 14, and 28.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- UPMC Cancer Centers
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
Toxicity profile and overall toxicity rates
|
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Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
|
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Biologic response rate
|
合作者和调查者
调查人员
- 首席研究员：Robert L. Ferris, MD, PhD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- 复发性转移性鳞状颈部癌伴隐匿性原发灶
- 转移性鳞状颈癌伴隐匿性原发性鳞状细胞癌
- III期唇和口腔鳞状细胞癌
- IV期唇和口腔鳞状细胞癌
- 唇和口腔复发性鳞状细胞癌
- III期口咽鳞状细胞癌
- IV期口咽鳞状细胞癌
- 复发性口咽鳞状细胞癌
- III期鼻咽鳞状细胞癌
- IV期鼻咽鳞状细胞癌
- 复发性鼻咽鳞状细胞癌
- 下咽部 III 期鳞状细胞癌
- 下咽部鳞状细胞癌 IV 期
- 下咽部复发性鳞状细胞癌
- III期喉鳞状细胞癌
- IV期喉鳞状细胞癌
- 复发性喉癌
- III期鼻窦和鼻腔鳞状细胞癌
- IV 期鼻窦和鼻腔鳞状细胞癌
- 鼻窦和鼻腔复发性鳞状细胞癌
- I期唇和口腔鳞状细胞癌
- II期唇和口腔鳞状细胞癌
- I期鼻窦和鼻腔鳞状细胞癌
- II期鼻窦和鼻腔鳞状细胞癌
- I期下咽鳞状细胞癌
- I期喉鳞状细胞癌
- I期鼻咽鳞状细胞癌
- I期口咽鳞状细胞癌
- II期下咽部鳞状细胞癌
- II期喉鳞状细胞癌
- II期鼻咽鳞状细胞癌
- II期口咽鳞状细胞癌
- 舌癌
其他研究编号
- PCI-03-156
- CDR0000515081 (注册表标识符：PDQ (Physician Data Query))
- PCI-0507062
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在美国制造并从美国出口的产品
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