Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of significant toxicity of tumor treating fields (TTFs)
研究概览
简要总结
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether the TTF device can be successfully placed in the three protocol-specified treatment field arrays (cervical, thoracic, and lumbar) and worn by the study patients for a meaningful period of time in the treatment of leptomeningeal metastases within the spine.
SECONDARY OBJECTIVE:
I. To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory [MDASI]-spine module).
OUTLINE:
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
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
- •Age >= 18
- •Prior tissue diagnosis of breast cancer or lung cancer
- •Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
- •Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
- •Life expectancy of at least 6 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
- •Recovery from any neurotoxic effects of prior therapy
- •Platelet count greater than 25 x 10^9/L
- •Absolute neutrophil count (ANC) greater than 0.5 x 10^9/L
- •Patients must have adequate liver function, total bilirubin < 2.5 mg/dL, unless elevated total bilirubin is due to elevated indirect bilirubin from known Gilbert's disease, aspartate aminotransferase (AST) =< 3.5 times upper limits of normal; adequate renal function [calculated estimated glomerular filtration rate (eGFR) >= 30 mL/min/ body surface area (BSA)]
- •Patients or legal medical representative must provide written informed consent
- •Patients must have suitable body habitus for placement of transducer arrays
- •Patients must be willing to wear the device for at least 18 hours a day (averaged over monthly)
- •Patients must be willing to return for the scheduled evaluations and perform the required assessments
- •Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF
- •Patient willing to start a study treatment with TTF =< 14 days from registration
排除标准
- •Concomitant therapy:
- •Must not be receiving concurrent high-dose methotrexate (>= 3 g/m^2), high dose thiotepa, or high-dose cytarabine (>= 3 g/m^2). Any other systemic chemotherapy, targeted treatment, hormonal or immunotherapy directed at the primary systemic malignancy is permitted
- •Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF
- •Must be at least 1 week from cessation of any prior intrathecal chemotherapy
- •Women of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy)
- •Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
- •Patients receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to registration. The 14-day period should be extended if the investigational agent is known to have delayed toxicity
- •Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
- •Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)
研究组 & 干预措施
Treatment (TTFields, digital photos)
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
干预措施: Digital Photography (Other)
Treatment (TTFields, digital photos)
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
干预措施: Lumbar Puncture (Procedure)
Treatment (TTFields, digital photos)
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (TTFields, digital photos)
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
干预措施: Medical Device Usage and Evaluation (Device)
Treatment (TTFields, digital photos)
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Incidence of significant toxicity of tumor treating fields (TTFs)
时间窗: Up to 3 years
Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Feasibility of TTFs - completion of at least 28 days of TTF therapy
时间窗: Up to 28 days
Assessed by the number of patients who are unable to complete at least 28 days of TTF therapy (a composite average for the 28 days of at least 50% of array 'on' time) due to unacceptable adverse events. Treatment with TTF will be considered feasible if the stopping rule is not reached, as defined per protocol.
Incidence of significant toxicity of tumor treating fields (TTFs)
时间窗: Up to 3 years
Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Feasibility of TTFs - completion of at least 28 days of TTF therapy
时间窗: Up to 28 days
Assessed by the number of patients who are unable to complete at least 28 days of TTF therapy (a composite average for the 28 days of at least 50% of array 'on' time) due to unacceptable adverse events. Treatment with TTF will be considered feasible if the stopping rule is not reached, as defined per protocol.
次要结局
- Preliminary signals of activity - CSF cytologic response(Up to 3 years)
- Preliminary signals of activity - time to CSF cytologic repsonse(Up to 3 years)
- Preliminary signals of activity - duration of CSF cytologic response(Up to 3 years)
- Preliminary signals of activity - neurologic progression-free survival(Up to 3 years)
- Preliminary signals of activity (defined as either suspicious or positive cytology).(Up to 3 years)
- Preliminary signals of activity - CSF cytologic response(Up to 3 years)
- Preliminary signals of activity - MRI radiographic response(Up to 3 years)
- Preliminary signals of activity - time to CSF cytologic repsonse(Up to 3 years)
- Preliminary signals of activity - duration of CSF cytologic response(Up to 3 years)
- Preliminary signals of activity - neurologic progression-free survival(Up to 3 years)
- Preliminary signals of activity (defined as either suspicious or positive cytology).(Up to 3 years)