Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
1 other identifier
interventional
30
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2015
CompletedStudy Start
First participant enrolled
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
March 17, 2026
March 1, 2026
12 years
April 22, 2015
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Adverse events
1 year
Progression free survival
1 year
Study Arms (1)
Meclofenamate
EXPERIMENTALAll enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.
Interventions
Eligibility Criteria
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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Baptist Health South Florida
Miami, Florida, 33143, United States
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Related Publications (1)
Laghetti P, Saltarella I, Dell'Atti S, Desaphy JF, Altamura C. Pleiotropic Effects of the NSAID Fenamates on Chloride Channels: Opportunity for Ion Channelopathies? Pharmacol Res Perspect. 2025 Aug;13(4):e70144. doi: 10.1002/prp2.70144.
PMID: 40568930DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrienne Boire, MD, PhD
Memorial Sloan Kettering Cance Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 29, 2015
Study Start
April 22, 2015
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
March 17, 2026
Record last verified: 2026-03