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

Pilot Study of 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Recurrent Brain Metastases; Progressive Brain Metastases
• Intervention / Treatment: Drug: Meclofenamate

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Baptist Health South Florida
  • New Jersey
    • Basking Ridge, New Jersey, United States
      • Memorial Sloan Kettering Cancer Center
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center at Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meclofenamate; All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.	Drug: Meclofenamate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)	The trial will be deemed "feasible" if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint.	2 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events (from all categories) will be collected, graded according to version 4.0 of the NCI Common Terminology Criteria for Adverse Events.	1 year
Progression free survival	progression-free survival is defined as time from start of treatment to progressive disease by MRI	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Adrienne Boire, MD, PhD, Memorial Sloan Kettering Cance Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2015
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimated): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: meclofenamate; 15-068
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Recurrence; Brain Neoplasms; Neoplasms, Second Primary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Meclofenamic Acid
• Other Study ID Numbers: 15-068