Clinical trial NCT02429570: Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Official title: Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Recurrent Brain Metastases
Progressive Brain Metastases
Keywords: meclofenamate
15-068
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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 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

Primary outcomes:
measure: Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)
timeFrame: 2 month
Secondary outcomes:
measure: Adverse events
timeFrame: 1 year
measure: Progression free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center at Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cance Center
name: Adrienne Boire, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: