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

This study is currently recruiting participants.
Verified October 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02429570
First Posted: April 29, 2015
Last Update Posted: October 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose

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 Intervention
Recurrent Brain Metastases Progressive Brain Metastases Drug: Meclofenamate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Actual Study Start Date: April 22, 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meclofenamate
All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.
Drug: Meclofenamate

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Adrienne Boire, MD, PhD 212-639-5371
Contact: Thomas Kaley, MD 212-639-5122

Locations
United States, Florida
Baptist Health South Florida Recruiting
Miami, Florida, United States, 33143
Contact: Yazmin Odia, MD    786-596-2000      
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Adrienne Borie, MD, PhD    212-639-5371      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Adrienne Boire, MD    212-639-5371      
United States, New York
Memorial Sloan Kettering Cancer Center at Commack Recruiting
Commack, New York, United States, 11725
Contact: Adrienne Boire, MD, PhD    212-639-5371      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Adrienne Boire, MD, PhD    212-639-5371      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Adrienne Boire, MD, PhD    212-639-5371      
Contact: Thomas Kaley, MD    212-639-5122      
Principal Investigator: Adrienne Boire, MD, PhD         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, MD    610-402-7880      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Adrienne Boire, MD, PhD Memorial Sloan Kettering Cance Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02429570     History of Changes
Other Study ID Numbers: 15-068
First Submitted: April 22, 2015
First Posted: April 29, 2015
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
meclofenamate
15-068

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases
Meclofenamic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action