EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma.
The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)
详细描述
Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.
TTFields intensity has been shown to be positively correlated with patient outcome. The new transducer array design is expected to reduce skin heating and thus enable delivery of higher TTFields intensities while keeping the safety profile of the treatment unchanged.
The purpose of the study is to test if delivering TTFields using high intensity transducer arrays for recurrent GBM significantly improves the clinical outcome of patients, compared to using the standard transducer arrays.
The study will enroll 25 patients.
All patients included in this clinical investigation are patients with histologically confirmed diagnosis of GBM with first or second radiological disease progression per RANO criteria.
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
盲法说明
Open label
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
- •Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- •Age ≥ 18 years
- •Not a candidate for further radiotherapy or additional resection of residual tumor.
- •Patients with first or second radiological disease progression per RANO criteria documented by MRI within 4 weeks prior to starting therapy with the following restriction: disease progression must be either growth of the enhancing lesion or a new lesion.
- •Karnofsky performance status ≥ 70
- •Life expectancy ≥ least 3 months
- •Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
- •All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- •Treatment start date at least 4 weeks out from brain surgery chemotherapy or irradiation therapy.
排除标准
- •Infratentorial or leptomeningeal disease
- •Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment.
- •Participation in another clinical treatment study during screening and treatment phase of the study.
- •Pregnancy or breast-feeding.
- •Significant co-morbidities at baseline, as determined by the investigator:
- •Thrombocytopenia (platelet count < 100 x 103/μL)
- •Neutropenia (absolute neutrophil count < 1 x 103/μL)
- •CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- •Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
- •Total bilirubin > 1.5 x upper limit of normal
- •Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l)
- •History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- •Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- •Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- •Admitted to an institution by administrative or court order.
- •Known allergies to medical adhesives or hydrogel
结局指标
主要结局
Progression free survival (PFS)
时间窗: 18 Months
PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.
次要结局
- Overall Survival (OS)(18 Months)
- Overall radiological response(18 Months)
- 1-year and 2-year survival rates(24 Months)
- Progression Free Survival at 6 months (PFS6)(18 Months)
- Severity and frequency of adverse events(18 Months)
- Pathological changes in resected GBM tumors following study treatment(18 Months)
- Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed(18 months)
- Dependence of Overall Survival on TTFields dose delivered to the tumor bed(18 months)