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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02429570

Collaborator

(none)

Enrollment

Locations

Arm

95.3

Anticipated Duration (Months)

4.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Brain Metastases Progressive Brain Metastases	Drug: Meclofenamate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 22, 2015

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meclofenamate All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.	Drug: Meclofenamate

Arm

Intervention/Treatment

Experimental: Meclofenamate

All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.

Drug: Meclofenamate

Outcome Measures

Primary Outcome Measures

Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint) [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 Outcome Measures

Adverse events [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 [1 year]
progression-free survival is defined as time from start of treatment to progressive disease by MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Health South Florida	Miami	Florida	United States	33143
2	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey	United States
3	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
4	Memorial Sloan Kettering Cancer Center at Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18103