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

Status:	Active, not recruiting
Conditions:	Brain Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - 80
Updated:	6/6/2018
Start Date:	April 22, 2015
End Date:	April 2019

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.

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

We found this trial at

sites

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey

Phone: 212-639-5371

from

Basking Ridge, NJ