Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary

Not Applicable

Active, not recruiting

Brief 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.

Recruitment & Eligibility

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 congestive heart failure requiring medical management

Arm && Interventions

Group	Intervention	Description
Meclofenamate	Meclofenamate	All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.

Primary Outcome Measures

Name	Time	Method
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 year	Adverse events (from all categories) will be collected, graded according to version 4.0 of the NCI Common Terminology Criteria for Adverse Events.
Progression free survival	1 year	progression-free survival is defined as time from start of treatment to progressive disease by MRI

Locations (6): Baptist Health South Florida
🇺🇸
Miami, Florida, United States
Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Memorial Sloan Kettering Cancer Center at Commack
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
Lehigh Valley Health Network
🇺🇸
Allentown, Pennsylvania, United States

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