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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-22

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases

NCT02360215

Cognitive Impairment Metastatic Malignant Neoplasm in the Brain Solid Neoplasm

COMPLETED PHASE3

Trametinib With or Without Whole Brain Radiation Therapy in Treating Patients With Brain Metastases

NCT02015117

Metastatic Malignant Neoplasm in the Brain

ACTIVE_NOT_RECRUITING PHASE1

Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases

NCT02621515

Melanoma Brain Metastasis

TERMINATED PHASE2

Whole-Brain Radiation Therapy and Pemetrexed in Treating Patients With Brain Metastases From Non-Small Cell Lung Cancer

NCT00280748

Lung Cancer Metastatic Cancer

TERMINATED PHASE2

Carmustine Implants in Treating Patients With Brain Metastases

NCT00003878

Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Brain Metastases Progressive Brain Metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Meclofenamate

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

Group Type EXPERIMENTAL

Meclofenamate

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Meclofenamate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No