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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary

Conditions
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Recurrent Brain Metastases, Progressive Brain Metastases

Intervention / Treatment
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* Drug: Meclofenamate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meclofenamate<br>All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID. | Drug: Meclofenamate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint) | The trial will be deemed feasible if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint. | 2 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meclofenamate, 15-068