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Nonsteroidal Anti-inflammatory Drug
Meclofenamate for Brain Cancer
N/A
Waitlist Available
Led By Adrienne Boire, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
There is no limit on the number of brain metastases
Age 18-80
Must not have
Known leptomeningeal metastases
Progressive systemic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a drug to see if it can prevent brain metastasis growth. This is the first time the drug is being used to treat brain metastasis, and researchers want to see if it's effective and safe.
Who is the study for?
This trial is for adults aged 18-80 with recurrent or progressive brain metastasis from solid tumors, visible on MRI. Participants must have a stable systemic disease or no evidence of disease and can't be pregnant, have had recent surgery, active bleeding issues, severe allergies to NSAIDs like meclofenamate, certain heart conditions, uncontrolled systemic cancer growth, or poor kidney/liver function.
What is being tested?
The study tests Meclofenamate's effectiveness in preventing new brain metastases in patients whose cancer has spread to the brain. It's a pilot study aimed at seeing if larger trials are feasible and understanding the drug's impact on both the patient and their brain metastasis.
What are the potential side effects?
Potential side effects may include digestive system issues due to Meclofenamate’s properties similar to common pain relievers (NSAIDs). Since it was previously used for pain relief, risks might mirror those associated with NSAID use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I may have multiple brain metastases.
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I am between 18 and 80 years old.
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I can care for myself but may need occasional help.
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I have at least one growing brain tumor from cancer that started elsewhere, visible on an MRI.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to the lining of my brain and spinal cord.
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My condition is getting worse over time.
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I have a heart rhythm problem that needs medication or a pacemaker.
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I am being treated for heart failure.
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I do not have an active brain bleed.
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I have not had any bleeding in my stomach or intestines in the last 6 months.
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I am currently on blood thinners.
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I currently have a bleeding disorder.
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My kidney function is low, shown by high creatinine or low clearance.
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I am allergic to certain anti-inflammatory drugs.
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I cannot take medicine by mouth.
Select...
My steroid dose was raised in the last two weeks.
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I am currently on medication to prevent blood clots.
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My cancer originated in the brain.
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I had surgery less than two weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)
Secondary study objectives
Adverse events
Progression free survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MeclofenamateExperimental Treatment1 Intervention
All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,470 Total Patients Enrolled
Adrienne Boire, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cance Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the lining of my brain and spinal cord.I may have multiple brain metastases.I have had surgery or SRS for some, but not all, of my recurrent cancer lesions.My condition is getting worse over time.I have a heart rhythm problem that needs medication or a pacemaker.I am being treated for heart failure.I do not have an active brain bleed.I have not had any bleeding in my stomach or intestines in the last 6 months.I am currently on blood thinners.I currently have a bleeding disorder.I cannot take medicine by mouth.I am between 18 and 80 years old.I can care for myself but may need occasional help.I have at least one growing brain tumor from cancer that started elsewhere, visible on an MRI.My cancer has returned after treatment, including surgery or radiation.My kidney function is low, shown by high creatinine or low clearance.I am allergic to certain anti-inflammatory drugs.My steroid dose was raised in the last two weeks.I am currently on medication to prevent blood clots.My cancer originated in the brain.I had surgery less than two weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Meclofenamate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.