Recurrent Brain MetastasesNCT02429570
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
A study testing Meclofenamate in people with Recurrent Brain Metastases and Progressive Brain Metastases, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Brain Metastases, Progressive Brain Metastases
- What is being tested?
- Meclofenamate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Apr 2015to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Baptist Health South Florida
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot Study of 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.
- Being tested
- Meclofenamate
- Keywords
- meclofenamate, 15-068
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeclofenamateDrug
| Study group | Role | What they receive |
|---|---|---|
| Meclofenamate | Experimental | All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID. Receives: Drug: Meclofenamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month
Secondary outcomes (2)
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.
Measured: 1 year
Progression free survival
progression-free survival is defined as time from start of treatment to progressive disease by MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start22 Apr 2015
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrienne Boire, MD, PhD, Principal investigator, Memorial Sloan Kettering Cance Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429570
- Sponsor's protocol ID
- 15-068
- Status last verified
- May 2026
- First submitted
- 22 Apr 2015
- Last updated
- 29 May 2026
- Results posted
- No
Publications
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.
PubMed 40568930
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
- ClinicalTrials.gov ID
- NCT02429570
- Acronym / sponsor ID
- 15-068
- Keywords
- meclofenamate, 15-068
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meclofenamate | Experimental | Drug: MeclofenamateAll enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- Inability to get brain MRI +/- contrast
- Progressive systemic disease
- Known leptomeningeal metastases
- Primary Brain tumor
- Active Intracranial Hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meclofenamate | Drug | Meclofenamate |
Primary outcome
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.
2 secondary outcomes
Adverse events
Time frame: 1 year
Progression free survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 40568930Laghetti 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Boire, MD, PhD principal investigator
Memorial Sloan Kettering Cance Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meclofenamate in people with Recurrent Brain Metastases and Progressive Brain Metastases, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint) (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.