Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with recurrent malignant glioma.
详细描述
Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of recurrent malignant glioma in 212 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 to 70 years old, signed ICF;
- •At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
- •KPS ≥ 60;
- •Unilateral, Supratentorial, solitary lesion and not crossing the midline(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions)
- •No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥ 4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥ 90 g/L; Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
- •Not Pregnant or lactating for women of childbearing potential.
排除标准
- •Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
- •Concomitant with other life-threatening diseases and with life expectancy <3 months;
- •Allergic to nitrosourea drugs;
- •With history of intracranial radiotherapy or implant chemotherapy;
- •With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
- •Investigators thought unsuitable for enrollment.
研究组 & 干预措施
Carmustine Sustained Release Implant
干预措施: Carmustine(BCNU) (Drug)
Surgical control group
干预措施: Surgery (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 12 months
次要结局
- Overall Survival Rate(12 months)
- Progress Free Survival Rate at 6 months(12 months)
- Tumor response rate(12 months)
- KPS Score(12 months)
- QOL Score(12 months)
- Safety of intracranially implanted carmustine after maximal tumor resection(12 months)