Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02429570|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2015
Last Update Posted : June 4, 2018
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary|
|Actual Study Start Date :||April 22, 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.
- Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint) [ Time Frame: 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.
- Adverse events [ Time Frame: 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 [ Time Frame: 1 year ]progression-free survival is defined as time from start of treatment to progressive disease by MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429570
|United States, Florida|
|Baptist Health South Florida|
|Miami, Florida, United States, 33143|
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Memorial Sloan Kettering Cancer Center at Commack|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Lehigh Valley Health Network|
|Allentown, Pennsylvania, United States, 18103|
|Principal Investigator:||Adrienne Boire, MD, PhD||Memorial Sloan Kettering Cance Center|