Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Progression free survival
研究概览
简要总结
Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.
- Trial with medicinal product
详细描述
Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.
The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent glioblastoma at least 2 cm in diameter after standard treatment (Surgery, Radiotherapy and Chemotherapy), which has to be completed at least three weeks earlier.
- •> 18 years of age, KPS 70-100%
- •No liver disease, no malignancies (except curative treated skin tumors, DCIS of the breast and curative treated cervix carcinoma)
- •Lc > 3000 und Tc > 100 000, Hb> 9, Bilirubin </= 1.5mg/dl, AST/ALT less than 2.5 x upper limit, creatinine </= 132umol/l
- •No pregnancy or breast feeding
- •Written Informed Consent prior to study entry
- •No reasons for incompliance
- •Reoperation planned
排除标准
- •KPS < 70%
- •Radiotherapy- or Chemotherapy within 6 weeks
- •Enzyme inducing medication or St John's wort
- •Other study medication within 28 days
- •Other malignancies
- •Intolerance of Patupilone
- •Prior Patupilone
- •Neuropathy > Grad 1
- •Other life threatening illnesses
- •Acute or chronic liver diseases
- •HIV Infection
- •Known non-compliance in medication intake,inability to give informed consent
- •Cardiac problems (NYHA III oder IV) with uncontrolled insufficiency or angina pectoris
- •Active or uncontrolled infection
- •Pregnancy or breast feeding
- •Hematologic Growth Factors (without Erythropoetin) colostomy
- •Patients with uncontrolled diarrhea in the last 7 days prior to study entry.
结局指标
主要结局
Progression free survival
时间窗: 3 years
PFS, OS translational research
时间窗: 3 years
次要结局
未报告次要终点