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Immunologic Responses in HPV-Associated Carcinoma for Patients Receiving Chemoradiation

Evaluation of Immunologic Responses in HPV-Associated Oropharyngeal Carcinoma Patients Receiving Chemoradiation Therapy

The primary purpose of this research is to investigate anti-tumor immune responses in patients undergoing chemotherapy and radiation for Head and Neck Cancers.

Hypothesis: Treatment of HPV-associated OPSCC with concurrent chemoradiation results in changes in the tumor microenvironment. We hypothesize that these changes during daily fractionated chemoradiotherapy can lead to detectable changes in HPV-specific tumor immune responses.

Hypothesis: HPV-specific cellular immune responses can still be detected during radiotherapy in the presence or absence of lymphopenia.

  • This study will determine whether specific anti-tumor immune responses (Specific Antibodies and Specific T-cells) can be detected in patients undergoing chemoradiation treatment for Head and Neck Cancers.
  • This study will evaluate the presence or absence of HPV (human papillomavirus) specific immune responses before, during, and after treatment for Head and Neck Cancers.
  • This study will also evaluate whether decreased white blood cell counts may affect development of immune responses in Head and Neck cancer patients undergoing treatment.

Any head and neck cancer patient undergoing concurrent chemoradiotherapy is eligible if: you are older than 18 years of age, capable of providing informed consent, have a life expectancy of greater than 4 months, and have a good performance status.

You are eligible irregardless of your HPV positive or negative status. People with HPV positive (human papillomavirus associated) head and neck cancer may join. People with HPV negative head and neck cancer may also join.

研究概览

详细说明

As this is a pilot study seeking to describe the potential impact of chemoradiotherapy on the natural history of any immunologic response in HPV-associated OPSCC, the timing of the venipunctures reflect the goal to sample throughout the course of CTRT (chemoradiation therapy)and will permit some variability based on the number of radiation fractions delivered. It also reflects considerations of time points that lend themselves to both the venipuncture and tumour biopsy based on the toxicity and response profile of the chemoradiation in the HPV-associated OPSCC patient. As such, 10 subjects with HPV-associated OPSCC and 10 subjects with non-HPV associated HNSCC seen by the respective disciplines of otolaryngology-head and neck surgery, radiation oncology, or medical oncology as clinically indicated will be enrolled on this clinical protocol. Importantly, clinical therapeutic recommendations, radiation treatment plans, and therapeutic drugs will not be altered by enrollment in this protocol. Tumors which are directly visible through in office laryngopharyngoscopy and easily accessible (i.e. oropharyngeal tonsil) will be directly biopsied (non-percutaneously) and analyzed as detailed below.

研究类型

观察性的

注册 (实际的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Baltimore、Maryland、美国、21287
        • The Johns Hopkins SKCCC

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

10 subjects with HPV-associated OPSCC (Oropharyngeal Squamous Cell Carcinoma) and 10 subjects with non-HPV associated HNSCC (Head and Neck Squamous Cell Carcinoma)

描述

Inclusion Criteria:

  • patients must have head and neck cancer and be receiving concurrent chemotherapy and radiation
  • patients greater than or equal to 18 years of age
  • patients must be capable of providing informed consent
  • patients must have a life expectancy of greater than 4 months
  • patients must have an adequate performance status

Exclusion Criteria:

  • Patients must not have had surgery for their head and neck cancer
  • Patients must not have a diagnosis of an immunosuppressant disease
  • Patients must not have certain uncontrolled concurrent illnesses
  • Patients must not a history of autoimmune disease
  • Patients must not be pregnant, become pregnant or breast feeding
  • Patients must not have a history of certain prior malignancies

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Chemoradiation with Research Samples
Standard of care chemoradiation therapy will be given as clinically indicated by the treating physicians. 4 research blood and tissue samples will be obtained. One before treatment starts, 2 while treatments are being received and finally one after treatments are completed.
research blood draw and tissue biopsy

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Compare Systemic and Local Immunologic Changes During Chemoradiation
大体时间:Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
Primary objective: To evaluate the systemic and local immunologic changes which may occur during a standard treatment course of combined chemoradiation for HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) and non-HPV associated head and neck squamous cell carcinomas (HNSCC).
Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion

次要结果测量

结果测量
措施说明
大体时间
Relationship of Radiotherapy-Related Lymphopenia and Changes in Cellular Immunity During Chemoradiation
大体时间:Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion
Secondary objective: To explore the relationship between radiotherapy-related lymphopenia and changes in cellular immunity during a course of chemoradiation for HPV-associated OPSCC.
Baseline within 1-3 weeks of start of radiation, week 2 between radiation fractions 10-12, week 4 between radiation fractions 20-22, 4-6 weeks after chemoradiation completion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Harry Quon, M.D.、Johns Hopkins SKCCC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年1月7日

初级完成 (实际的)

2017年2月15日

研究完成 (实际的)

2017年3月15日

研究注册日期

首次提交

2013年10月7日

首先提交符合 QC 标准的

2013年10月8日

首次发布 (估计)

2013年10月9日

研究记录更新

最后更新发布 (实际的)

2018年11月6日

上次提交的符合 QC 标准的更新

2018年11月5日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • J13158
  • IRB00092006 (其他标识符:JHMIRB)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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