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

Recurrent Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02429570
• Other study ID #: 15-068
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2015
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Progressive Brain Metastases
• Recurrence
• Recurrent Brain Metastases

Intervention

Drug:
• Meclofenamate

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Memorial Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Baptist Health South Florida	Miami	Florida
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression free survival	progression-free survival is defined as time from start of treatment to progressive disease by MRI	1 year

External Links

•   Memorial Sloan Kettering Cancer Center