Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in IFN-gamma Levels
研究概览
简要总结
The poor survival of Veterans with oral cancer underscores the significance of identifying new treatment approaches. The proposed studies will test a new 2 pronged immunotherapeutic approach for oral cancer patients which lessen the immune inhibitory environment while maturing cells that can stimulate T cell reactivity against oral cancer cells.
详细描述
The hypothesis of this study is beneficial T cell reactivity in oral squamous cell carcinoma (OSCC) tumors can be synergistically stimulated by blocking suppressor endothelial cells and their induction of other inhibitory cell populations while also maturing immune inhibitory CD34+ cells into antigen-presenting dendritic cells.
To test this hypothesis, newly diagnosed OSCC patients will be administered the cyclooxigenase 2 inhibitor celecoxib and/or Calcitriol for the 3 week duration between cancer diagnosis and surgical treatment. The following aims will test the immunological and clinical effectiveness of the combination treatment:
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- To block the suppressive activity of endothelial cells and increase the levels of dendritic that are stimulatory to T cell reactivity, thereby synergistically increasing intratumoral T cell reactivity. These functional immune analyses will use OSCC tissues removed from untreated patients or patients treated with celecoxib and/or Calcitriol.
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- To reduce development of OSCC recurrences by synergistically stimulating intratumoral T cell reactivity with celecoxib to block suppressor endothelial cell activity and Calcitriol to mature CD34+ suppressor cells into T cell stimulatory dendritic cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locoregional OSCC (T stage II-IV) of the oral cavity, oropharynx, larynx, or hypopharynx without evidence of distant metastases
- •greater than or equal to 18 years of age
- •the OSCC treatment plan includes surgical resection
- •performance status of 0 or 1
- •recovered from any prior surgery
- •must be willing to use appropriate contraception if of child-bearing potential
- •give signed informed consent prior to the initiation of therapy
排除标准
- •prior immunotherapy
- •chemotherapy or radiation therapy within three weeks
- •concurrent NSAID treatments while undergoing treatment
- •women pregnant or lactating
- •HIV positive
- •have an active infection requiring antibiotic therapy, or concomitant malignancies
- •history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
研究组 & 干预措施
Arm 1: Celecoxib
Celecoxib treatment prior to surgery
干预措施: Celecoxib (Drug)
Arm 2: Calcitriol
Treatment with Calcitriol prior to surgery
干预措施: Calcitriol (Drug)
Arm 3: Celecoxib plus Calcitriol
Treatment with Celecoxib plus Calcitriol prior to surgery.
干预措施: Celecoxib plus Calcitriol (Drug)
结局指标
主要结局
Change in IFN-gamma Levels
时间窗: baseline and 3 weeks
Change in IFN-gamma stimulatory cytokine levels within tumor tissue.
Change in IL-6 Levels.
时间窗: baseline and 3 weeks
Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.
Change in IL-2 Levels
时间窗: baseline and 3 weeks
Change in IL-2 stimulatory cytokine levels within tumor tissue.
Change in GM-CSF
时间窗: baseline and 3 weeks
Change in GM-CSF stimulatory cytokine levels within tumor tissue.
次要结局
未报告次要终点