Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary (NCT02429570) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
United States30 participantsStarted 2015-04-22
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-80
* KPS ≥ 60
* 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.
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)