NCT00209989已完成2 期
Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy
研究概览
简要总结
The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have pathologically confirmed (histology or cytology), resectable or non resectable, glioblastoma multiforme with a size < 5 cm on MRI if non resectable
- •Patients must be at least 7 days but no more than 2 months since surgery or biopsy.
- •Patients must have an ECOG Performance Status ≤
- •Patients must be aged 18
- •Patient has signed the informed consent form
排除标准
- •Patients with unresectable glioblastoma with a size >5 cm on MRI
- •Patients with clinically apparent leptomeningeal metastases
- •Patients with uncontrolled seizures despite standard anticonvulsant therapy
- •Any prior systemic treatment (chemotherapy, immunotherapy, hormonal therapy) for glioblastoma multiforme
- •Significantly abnormal haematological status as judged by:
- •Absolute neutrophil count (ANC) < 1500/mm3 (1.5*109/l) Platelet count <100,000/mm3 (100*109/l)
- •Serum bilirubin >2 mg/dl (>34 mmol/l) or Transaminase >2.5x the upper limit of institutional normal or Creatinine >1.5 mg/dl (>132 mmol/l)
- •Inability to co-operate with the treatment protocol
- •Patients who cannot undergo imaging evaluations
- •Participation in an investigational drug trial in the 30 days prior to selection
- •Pregnant or nursing mothers. (Female patients of childbearing potential must use adequate contraception.)
- •Any malignancy within the past five years. Exceptions are: superficial basal cell carcinoma or non-metastatic squamous cell cancer of the skin, cervix cancer (cervical intra-epithelial neoplasia -CIN or FIGO stage 1) or prostate intra-epithelial neoplasia (PIN), biochemical relapse free for at least 3 years.
- •Any prior systemic chemotherapy in the past five years for any malignancy in the medical history
- •Any concurrent disease that in the opinion of the investigator would constitute a hazard for participating in this study
- •Known sensitivity to imidazole derivatives
- •Patients under law protection
- •Medical history of phlebitis or pulmonary embolism, thrombocytosis, myocardiopathy, or other relevant cardiac pathology (auricular flutter, auricular fibrillation)
- •Medical history of immuno-allergic pneumopathy
结局指标
主要结局
Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy
时间窗: time of study
次要结局
- Objective response rate (RECIST and volumetric criteria)(time of study)
- Median survival, 6 month and 1 year survival rates(6 month and 1 year)
- Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters(time of study)
研究者
研究点 (3)
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