Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Skin and Connective Tissue Diseases

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Lung Neoplasms

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Breast Neoplasms

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Neoplasms, Second Primary

Brain Neoplasms

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Patients receive Cabazitaxel 25 mg/m2 i.v. infusion. This trial is a single arm trial.

Cabazitaxel 25 mg/m2 i.v. infusion (infusion time about 1h) on D1 of each 21-day cycle. Continuation of treatment until progression of brain metastases or unacceptable toxicity.

Cabazitaxel

Frank Kullmann, Prof. Dr.

Patients suffering from histologically or cytologically confirmed stage IV lung or breast cancer with progressive or recurrent brain metastases after prior external beam radiotherapy will receive treatment with cabazitaxel until progression of brain metastases (BM) or unacceptable toxicity.

Cabazitaxel is a new taxane compound that exhibited a broad spectrum of in vivo antitumor activity, not only in docetaxel - sensitive tumor models, but also in tumors models in which docetaxel was poorly or not active. In contrast to other taxanes, cabazitaxel has the ability to cross the blood-brain-barrier. Marked antitumor activity was obtained in nude mice bearing intracranial glioblastomas. Consequently, there is a good rationale to investigate cabazitaxel in patients with breast or lung cancer and recurrent or progressive brain metastases.

The primary object of the study is to measure objective tumor response of brain metastases for patients with breast or lung cancer and recurrent or progressive brain metastases.

A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

A Phase II Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)

Objective tumor response of brain metastases (Complete response (CR) or partial response (PR) or at least a minor response (MR; 25-50% reduction) according to WHO criteria1,2 and Iwamoto3 confirmed by magnetic resonance imaging (MRI))

Efficacy measure, assessed with EORTC QLQ-C30 and additional module BN20 questionnaire

ClinAssess GmbH

Sanofi

AIO-Studien-gGmbH

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Meclofenamic Acid

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

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

Meclofenamate

Adrienne Boire, MD, PhD

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.

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

The trial will be deemed "feasible" if at least 50% of patients enrolled are evaluable in brain by MRI at the 2-month timepoint.

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 is defined as time from start of treatment to progressive disease by MRI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Cabazitaxel for Patients With Breast or Lung Cancer and Recurrent or Progressive Brain Metastases - Cabazitaxel for Brain Metastases (CaBaMet)	NCT02166658	Breast Cancer Lung Cancer Recurrent Brain... Progressive Bra...	Cabazitaxel	18 Years -	AIO-Studien-gGmbH
Meclofenamate in Subjects With Recurrent or Progressive Brain Metastasis From Solid Tumor Primary	NCT02429570	Recurrent Brain... Progressive Bra...	Meclofenamate	18 Years - 80 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for progressive brain metastases