Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Running, not enrolling · Not applicable
Conditions studied: Recurrent Brain Metastases, Progressive Brain Metastases
In brief
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.
Key facts
- Study ID
- NCT02429570
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 30
- Starts
- 2015-04-22
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Baptist Health South Florida — Miami, Florida, United States
- Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
- Memorial Sloan Kettering Cancer Center at Commack — Commack, New York, United States
- Memorial Sloan Kettering Westchester — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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