NCT00890032已完成1 期
Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial
John Sampson1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility and safety
研究概览
简要总结
RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).
详细描述
OBJECTIVES:
Primary
- To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma multiforme.
Secondary
- To assess humoral and cellular immune responses to vaccination.
- To compare the proportion of vaccinated patients alive at 6 months from the time of surgery for recurrent tumor with matched historical cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years of age
- •First recurrence of GBM (WHO Grade IV glioma or astrocytoma) in surgically accessible areas with prior histologic diagnosis of GBM
- •No known contraindications to receiving Avastin
- •Karnofsky Performance Status (KPS) of > 70%
- •Radiation Therapy (RT) with ≥ 45 Gy tumor dose, completed ≥ 8 weeks prior to study entry
排除标准
- •Contrast-enhancing tumor component crossing the midline, multi-focal tumor, or tumor dissemination (subependymal or leptomeningeal)
- •Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- •Pregnant or need to breast feed during the study period (Negative beta-human chorionic gonadotropin (HCG) test required), or unable to maintain use of contraception while on study
- •Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F) illness
- •Known immunosuppressive disease, autoimmune disease or human immunodeficiency virus infection, Hepatitis B or Hepatitis C
- •Unstable or severe intercurrent medical conditions such as severe heart (New York Association Class 3 or 4) or lung (FEV1 < 50%) disease, uncontrolled diabetes mellitus
- •Prior brachytherapy, carmustine wafer therapy, radiolabeled monoclonal antibodies, or stereotactic radiosurgery
- •Prior inguinal lymph node dissection
- •Avastin-Specific Exclusion Criteria
- •Subjects meeting any of the following criteria are ineligible for study entry:
- •Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg)
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to enrollment
- •History of stroke or transient ischemic attack within 6 months prior to enrollment
- •Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to enrollment)
- •History of hemoptysis (> or = 1/2 teaspoon of bright red blood per episode) within 28 days prior to enrollment
- •Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrollment
- •Serious, non-healing wound, active ulcer or untreated bone fracture
- •Proteinuria as defined by > +1 on urinalysis dipstick
- •Known hypersensitivity to any component of Avastin
- •Pregnant (positive pregnancy test) or lactation
研究组 & 干预措施
BTSC mRNA-loaded DCs
Experimental
BTSC mRNA-loaded DCs administered intradermally weekly for first 3 vaccines, then monthly until progression or withdrawal.
干预措施: BTSC mRNA-loaded DCs (Biological)
结局指标
主要结局
Feasibility and safety
时间窗: 12 months
次要结局
- Humoral and cellular immune responses(12 months)
研究者
John Sampson
Professor of Neurosurgery
Duke University
研究点 (1)
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