A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 24
- 主要终点
- Overall Survival
研究概览
简要总结
This is a non-randomized, concurrent control study, designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients. The device is a portable, battery operated device that was approved for the treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
详细描述
PAST CLINICAL EXPERIENCE:
The effect of the electric fields generated by the NovoTTF-100A device (TTFields, TTF) has been tested in a large prospective, randomized trial, in 237 recurrent GBM patients. The outcome of subjects treated with the NovoTTF-100A device was compared to those treated with an effective best standard of care chemotherapy (including bevacizumab). NovoTTF-100A subjects had comparable overall survival to subjects receiving the best available chemotherapy in the US today. Similar results showing comparability of NovoTTF-100A to BSC chemotherapy were seen in all secondary endpoints.
Recurrent GBM patients treated with the NovoTTF-100A device in this trial experienced fewer side effects in general, significantly fewer treatment related side effects, and significantly lower gastrointestinal, hematological and infectious adverse events compared to controls. The only device-related adverse events seen were a mild to moderate skin irritation beneath the device electrodes. Finally, quality of life measures were better in NovoTTF-100A subjects as a group when compared to subjects receiving effective best standard of care chemotherapy.
DESCRIPTION OF THE TRIAL:
Patients with GBM whose disease has first recurred despite standard treatment (Surgery, radiation therapy, Temozolomide treatment) and meet all of the requirements for participation in the study will be recruited to one of two groups based on patient preference alone:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years of age or older
- •Histological diagnosis of GBM (WHO grade IV)
- •Tumor located in the supra-tentorial region of the brain
- •Received maximal, safe, surgical resection
- •Received maximal radiation therapy
- •Received concomitant Temozolomide
- •Received maintenance Temozolomide
- •First recurrence (based on radiological or histological evidence of recurrence)
- •Karnofsky performance score 70 or above
- •MMSE score 25 or above
- •Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
- •Women of childbearing age must be on effective contraception
- •Signed informed consent
- •Stable steroid dose in past 4 weeks
排除标准
- •Implanted electronic medical device in the brain:
- •Deep brain stimulator
- •Vagus nerve stimulator
- •Programmable shunt
- •Skull defect without replacement
- •Unable to comply with treatment with the NovoTTF-100A device
- •Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)
- •Second or subsequent recurrence
- •Any prior cytotoxic chemotherapy except Temozolomide
- •Actively participating in another therapeutic clinical trial
- •Radiological suspicion of pseudoprogression or radionecrosis
- •Radiation therapy or surgery in the past 4 weeks
- •Unable to comply with the study follow-up schedule
- •Any serious co-morbidity which is expected to affect survival more adversely than GBM
结局指标
主要结局
Overall Survival
时间窗: 5 years from initiation of accrual
次要结局
- Change in neuro-cognitive function from baseline based on MMSE(5 years from initiation of accrual)
- Genetic profiling of tumors and correlation with response to NovoTTF-100A treatment(5 years from initiation of accrual)
- Adverse events severity and frequency(5 years from initiation of accrual)