Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02429570

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Health South Florida, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meclofenamate

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Progression free survival

    Time frame: 1 year

    progression-free survival is defined as time from start of treatment to progressive disease by MRI

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2015
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.