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

Condition(s) targeted: Recurrent Brain Metastases; Progressive Brain Metastases

Intervention: Meclofenamate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Adrienne Boire, MD, PhD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cance Center

Overall contact:
Adrienne Boire, MD, PhD, Email: boirea@mskcc.org

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.

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)

Secondary outcome:

Adverse events

Progression free survival

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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 or 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

Adrienne Boire, MD, PhD, Email: boirea@mskcc.org

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States; Recruiting
Adrienne Borie, MD, PhD, Email: boirea@mskcc.org

Memorial Sloan Kettering Cancer Center at Commack, Commack, New York 11725, United States; Recruiting
Adrienne Boire, MD, PhD, Email: boirea@mskcc.org

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Adrienne Boire, MD, PhD, Email: boirea@mskcc.org
Thomas Kaley, MD, Phone: 212-639-5122
Adrienne Boire, MD, PhD, Principal Investigator

Memorial Sloan Kettering Cancer Center

Starting date: April 2015
Last updated: August 20, 2015