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

Primary Purpose

Recurrent Brain Metastases, Progressive Brain Metastases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meclofenamate
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Brain Metastases focused on measuring meclofenamate, 15-068

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Health South Florida
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Cancer Center at Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Lehigh Valley Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meclofenamate

Arm Description

All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2015
Last Updated
September 8, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02429570
Brief Title
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Official Title
Pilot Study of Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2015 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Brain Metastases, Progressive Brain Metastases
Keywords
meclofenamate, 15-068

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meclofenamate
Arm Type
Experimental
Arm Description
All enrolled patients will receive the study drug, meclofenamate at 100 mg PO BID.
Intervention Type
Drug
Intervention Name(s)
Meclofenamate
Primary Outcome Measure Information:
Title
Feasible (if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint)
Description
The trial will be deemed "feasible" if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint.
Time Frame
2 month
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events (from all categories) will be collected, graded according to version 4.0 of the NCI Common Terminology Criteria for Adverse Events.
Time Frame
1 year
Title
Progression free survival
Description
progression-free survival is defined as time from start of treatment to progressive disease by MRI
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne Boire, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cance Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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

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