A Multicenter, Open-Label, Randomized Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Toxicity associated with treatment with NovoTTF-200A alone and combined with temozolomide
研究概览
简要总结
The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device in patients with low-grade glioma when it's used by itself or used together with temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or without temozolomide, is associated with fewer negative side effects on mental function that may be seen with other currently used treatment options.
详细描述
Approximately 2,000 to 3,000 low-grade gliomas (LGGs) are diagnosed in adults each year in the United States. Based on a variety of prognostic factors the median overall survival ranges from 3 to 9 years.
NovoTTF-200A is a device that produces alternating electrical fields within the human body that disrupt cell division. These very low intensity intermediate frequency electric fields (TTFields) impair the growth of tumor cells through the arrest of cell division and inducing apoptosis.
Although FDA approved for the treatment of recurrent or progressive glioblastoma, further investigation of NovoTTF-200A is warranted, in the setting of low-grade glioma where it has the potential to stunt tumor growth without significant toxicity. NovoTTF-200A has also been shown to be safe combined with adjuvant 5-day temozolomide regimen in newly diagnosed glioblastoma in an ongoing clinical trial. Given the low proliferative index in low-grade gliomas, combining NovoTTF-200A with metronomic chemotherapy may be more effective.
This is a randomized, 2-arm, open label study of NovoTTF-200A alone or combined with daily temozolomide for the treatment of patients with newly diagnosed low-grade gliomas.
Patients will be randomized 1:1 to one of two arms for a total of 22 patients (11 per arm). Arm A will receive NovoTTF-200A only and Arm B will receive NovoTTF-200A and low-dose (50 mg/m2) daily temozolomide regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed low-grade glioma including astrocytoma grade 2, oligodendroglioma grade 2, or oligoastrocytoma grade
- •Tumor is supratentorially located and measureable.
- •Disease that has not received prior radiation, radiosurgery, chemotherapy, or other investigational treatment directed at the brain tumor at any time. Previous surgical procedures is allowed.
- •Age ≥ 18 years.
- •Life expectancy > 12 weeks.
- •Either not receiving steroids for disease symptoms or are on stable dose of steroids for at least 5 days.
- •Karnofsky Performance Status (KPS) ≥ 60%
- •Adequate hematologic function evidenced by:
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •Hemoglobin ≥ 9.0 g/dL
- •Adequate renal function evidenced by:
- •AST/SGOT and ALT/SPGT ≤ 2.5 X institutional upper limit of normal
- •Total bilirubin ≤ 1.5 x institution's ULN
- •Serum creatinine ≤ 1.5 x institution's ULN
排除标准
- •Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors are not eligible.
- •Current or anticipated use of other investigational agents.
- •Implanted electronic medical device in the brain (e.g., deep brain stimulator, vagus nerve stimulator, programmable shunt).
- •Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing.
- •Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
- •Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
- •Pregnant or nursing.
研究组 & 干预措施
Arm A
NovoTTF-200A
干预措施: NovoTTF-200A (Device)
Arm B
NovoTTF-200A + Temozolomide 50 mg/m2 daily (oral)
干预措施: NovoTTF-200A (Device)
Arm B
NovoTTF-200A + Temozolomide 50 mg/m2 daily (oral)
干预措施: Temozolomide (Drug)
结局指标
主要结局
Toxicity associated with treatment with NovoTTF-200A alone and combined with temozolomide
时间窗: 24 months
Participants will be assessed for the development of toxicity according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. Dose adjustments will be made according to the system showing the greatest degree of toxicity.
次要结局
- Effects of NovoTTF-200A alone and combined with temozolomide on seizure activity(24 months)
- Efficacy of NovoTTF-200A alone and combined with temozolomide(24 months)
- 12-month objective response rate (ORR) of NovoTTF-200A alone and combined with temozolomide(12 months)
- Effects of NovoTTF-200A alone and combined with temozolomide on quality of life (QOL)(24 months)
- Frequency of transformation from low-grade glioma into high-grade glioma(24 months)
研究者
Santosh Kesari
Associate Professor
Saint John's Cancer Institute