Surgical Resection With Gliadel Wafer Followed by Dendritic Cells Vaccination for Malignant Glioma Patients (Gliadel Wafer)
A Phase l Trial of Surgical Resection With Gliadel Wafer Placement Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate for Patients With Malignant Glioma
Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 12 months, with 90 - 95% of patients surviving less than 2 years. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain (i.e., young) patient subpopulations.
Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells as foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell (DC) vaccines.
Dendritic cells are a small group of cells contained in everyone's white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system.
gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a chemotherapy agent. These wafers are placed into the brain cavity after the tumor is resected (removed) and deliver a steady amount of immediate chemotherapy medicine to the surrounding brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the detrimental suppression (weakening) of the immune system shown with systemic (throughout the body) chemotherapy.
In prior Phase l and phase ll studies, patients who received chemotherapy following Dendritic cells demonstrated longer progression free and overall survival than the patients who received Dendritic cells or chemotherapy alone.
The purpose of this study is to determine whether after standard therapy of tumor resection surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic cell vaccines will not only generate (start) an immune response, but will provide longer progression free survival.
Patients who were screened and not enrolled in this clinical trial due to screen failure will be notified of the reason for screen failure. Pre HIV counseling and appropriate referral resources will be provided. If the screen failure is due to the positive HIV test, appropriate post HIV counseling will be provided and appropriate referrals will be made. The charts of the patients with screen failures will be destroyed.The patients charts who will be enrolled in the study kept in the locked cabinet in the research office. patients will be assigned a unique identifying code known only to the research team. Data will be captured by various source documents, or, as necessary, abstracted from hospital medical records by an experienced registered nurse. The electronic data for viral testing will be accessible to research personnel only.
研究概览
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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California
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Los Angeles、California、美国、90048
- Cedars Sinai Medical Center
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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
Inclusion Criteria:
- Patients must have a histopathological diagnosis of malignant glioma
- Patients must have undergone surgery and placement of Gliadel wafer.
- Women of child bearing potential must use medically accepted form of birth control.
- A Karnofsky performance status of at least 60%
- Must be off of steroid at least two weeks prior to vaccination
- Hematologic and metabolic panel results will be within the parameters of the protocol.
- Must be capable of IRB approved Informed Consent.
Exclusion Criteria:
- Patients with systemic disease
- Presence of acute infection
- Contraindication to MRI
- Known history of autoimmune disorder
- Pregnancy
- Positive for hepatitis B, C, HIV, syphilis, HTLVa nd HCV
- Allergic to Gentamicin.
- Inability to participate as per Principal Investigator's discretion.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 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 |
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实验性的:1个
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Patients will receive three vaccines every two weeks
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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To assess the survival of malignant glioma a, to assess the immunogeneicity of patients who receive Dendritic cell vaccine , to assess progression free survival and to evaluate quality of life.
大体时间:1 year
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1 year
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合作者和调查者
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
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.
Dendritic cell Vaccine的临床试验
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SENAI CIMATEC招聘中
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Beijing Center for Disease Control and PreventionBeijing Minhai Biotechnology Co., Ltd完全的健康 | 狂犬病