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A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer

2014年5月7日 更新者:Sang-Young Ryu、Korea Cancer Center Hospital

A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer

Among the immune cell therapy, autologous adoptive immune cell therapy is a method to transfer the immune cells derived from peripheral white blood cells and expanded and stimulated with various cytokines and tumor specific antigens in cancer patients. Recently, the low-dose radiation is known to increase the immune response in many human cancer patients. In a clinical trial, 70% response rate with combination of low-dose radiation and adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to investigate the feasibility of combination of low-dose radiation and autologous immune cell therapy in recurrent cervical cancer which is resistant to conventional palliative treatment.

研究概览

详细说明

Immune cell therapy is considered one of the most promising anti-cancer strategy in many human cancers. Compared to the destructive methods such as surgery, radiation, and chemotherapy, anti-cancer immune therapy is safer and less toxic method in the treatment of human cancer patients.

Among the immune cell therapy, autologous adoptive immune cell therapy is a method to transfer the immune cells derived from peripheral white blood cells and expanded and stimulated with various cytokines and tumor specific antigens in cancer patients. Recent development of the technique to expand immune cells ex vivo make autologous adoptive immune cell therapy much more feasible and popular. However, immune cell therapy showed response of below 10% currently in several clinical trials. The reason of poor response is that the adopted immune cells have to overcome the highly immune compromised environment in advanced or recurrent cancer patients.

The low-dose radiation, defined as the radiation below the therapeutic dose range, is known to increase the immune response in many human cancer patients. Despite the exact mechanism is not well known, the 'danger signal' and the decrease of T-regulatory cells by low-dose radiation are the possible mechanism of enhanced immunity by low-dose radiation. So, the combination of low-dose radiation and immune cell therapy can be a attractive strategy to recurrent or advanced cancer patients who are resistant to conventional treatment.

A challenging clinical trial performed in recurrent melanoma cancers, Dr. Rosenverg reported around 70% response rate with combination of low-dose radiation and adoptive immune cell therapy. However, the feasibility of combination of low-dose radiation and immune cell therapy is still unknown in many human cancers.

This study is to investigate the feasibility of combination of low-dose radiation and autologous immune cell therapy in recurrent cervical cancer which is resistant to conventional palliative treatment. The cervical cancer, highly responsive to radiation, becomes resistant to radiation in case of recurrent disease. We hypothetize that if the low-dose radiation can reverse the immune compromised environment, adoptive immune cells derived from the autologous peripheral blood immune cells will be highly effective in recurrent cervical cancers.

研究类型

介入性

注册 (实际的)

2

阶段

  • 阶段2
  • 阶段1

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

    • Nowon-Gu
      • Seoul、Nowon-Gu、大韩民国、139-706
        • Sang-Young Ryu

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 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  1. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  2. Age 18-75 years
  3. Pathologically proven recurrent or persistent cervical cancer patients resistant to conventional palliative chemotherapy or radiation therapy

    1. Persistent tumor more than 1cm after initial chemoradiation or radiation therapy
    2. Persistent tumor more than 1cm after chemoradiation, radiation or chemotherapy in recurrent cervical cancer
    3. Metastatic cervical cancer to lung resistant to conventional chemotherapy
  4. ECOG performance status 0, 1, 2.
  5. Expected survival more than 3 months
  6. Patients must have adequate:

    Hematologic function: ANC ≥ 1,500/mcl, Hemoglobin >10g/dL, platelets ≥ 100,000/mcl Renal function: creatinine ≤ 1.5 x ULN Hepatic function: AST, ALT ≤ 1.5 x ULN,

  7. More than 3 weeks from the last day of previous chemotherapy or radiation

Exclusion Criteria:

  1. Patients with immune disease or auto-immune disease (ex. rheumatoid arthritis, SLE, immune vasculitis, IDDM)
  2. Immune deficiency disease
  3. Cancers other than cervical cancer within 5 years
  4. Acute myocardial infarction, uncontrolled hypertension
  5. Severe allergic disease
  6. Severe psychotic disease
  7. Those who can be a candidate for curative surgery

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

  • 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)

武器和干预

参与者组/臂
干预/治疗
实验性的:Low dose radiation, Immune cell therapy
Combination treatment of low-dose radiation 20cGy every 3 weeks three times and autologous immune cell therapy 2 consecutive weeks 3 times every 3 weeks
InnoLak two consecutive weeks every 3 weeks for 3 times
其他名称:
  • InnoLAK
20cGy whole body radiation every three weeks for three times
其他名称:
  • Whole body radiation

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
Response rate
大体时间:12months
Response rate according to RECIST criteria for 12 months
12months

次要结果测量

结果测量
措施说明
大体时间
Toxicity
大体时间:12months
Toxcity according to CTCSEver4.0
12months

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:Sang-Young Ryu, MD、Korea Institute of Radiological & Medical Sciences

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

2010年9月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2010年9月2日

首先提交符合 QC 标准的

2010年9月2日

首次发布 (估计)

2010年9月3日

研究记录更新

最后更新发布 (估计)

2014年5月9日

上次提交的符合 QC 标准的更新

2014年5月7日

最后验证

2014年5月1日

更多信息

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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