Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)
研究概览
简要总结
Cancer that has spread to the brain, or brain metastasis, is difficult to treat. Meclofenamate is a drug which has been shown to reduce brain metastasis growth in the laboratory. This medicine has been used in the past to treat pain. But, in this study, it will be used to prevent new brain metastasis. This is the first time that meclofenamate will be used in patients with brain metastasis.
This is a pilot study which means that the purpose of this study is to determine if a larger clinical trial of meclofenamate is possible in patients with brain metastasis. This study also aims to find out what effects, good and/or bad meclofenamate has on the patient and the cancer that has spread to the brain. The investigators also want to learn more about potential effects that this drug may have in the digestive system.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •At least one recurrent or progressive brain metastasis (es) from any solid primary tumor that is visible on MRI as assessed by the patient's treating physician.
- •Recurrence may occur after any treatment: recurrence after whole-brain radiation, stereotactic radiosurgery, surgical resection, systemic chemotherapy are all acceptable.
- •There is no limit on the number of brain metastases.
- •Surgical resection or SRS to other recurrent lesions in the same patient are acceptable, provided one recurrent lesion remains untreated.
- •Systemic disease must be well-controlled or NED in the opinion of the patient's primary oncologist.
排除标准
- •Inability to get brain MRI +/- contrast
- •Progressive systemic disease
- •Known leptomeningeal metastases
- •Primary Brain tumor
- •Active Intracranial Hemorrhage
- •Surgery less than two weeks before enrollment
- •GI hemorrhage (active or in recent 6 months)
- •Concurrent anti-platelet therapy
- •Concurrent anti-coagulation therapy
- •Active bleeding diathesis
- •Platelet count ≤ 70,000/mm3
- •International normalized ratio (INR) > 1.6 and a Partial Thromboplastin Time (PTT) > 40 seconds
- •Serum Creatinine >2 mg/dL OR CrCL <30ml/min
- •AST or ALT > 200 U/L
- •Hemoglobin <8 g/dL
- •Allergy to meclofenamate or other NSAID
- •Inability to tolerate PO dosing
- •Steroid dose increased in the most recent two weeks.
- •Pregnancy
- •Cardiac Arrhythmia requiring medical management and/or pacemaker.
- •Known congestive heart failure requiring medical management
研究组 & 干预措施
Meclofenamate
All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.
干预措施: Meclofenamate (Drug)
结局指标
主要结局
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)
时间窗: 2 month
The trial will be deemed "feasible" if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint.
次要结局
- Adverse events(1 year)
- Progression free survival(1 year)