Progressive Brain Metastases, Recurrent Brain Metastases
Conditions
Keywords
meclofenamate, 15-068
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.
Interventions
DRUGMeclofenamate
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdrienne Boire, MD, PhD
Memorial Sloan Kettering Cance Center
Outcome results
None listed