NCT Number: NCT02429570
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Baptist Health South Florida, Miami, Florida, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)
Time frame: 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 outcomes
-
Adverse events
Time frame: 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
Time frame: 1 year
progression-free survival is defined as time from start of treatment to progressive disease by MRI
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Registry information
Official study title
Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Important dates
- Study start
- 2015
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 29, 2015
- Registry last updated
- May 29, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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