Terminé

A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Bevacizumab

Médicament
Qui peut participer

Maladies du cerveau+7

+ Néoplasmes cérébraux

+ Maladies du système nerveux central

À partir de 18 ans
+28 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 1 & 2
Interventionnel
Date de début : juin 2009
Voir le détail du protocole

Résumé

Sponsor principalM.D. Anderson Cancer Center
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juin 2009

Date à laquelle le premier participant a commencé l'étude.

The Study Drug: Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Study Drug Administration: If you are found to be eligible to take part in this study, every 2 weeks, you will receive bevacizumab by vein over about 1 hour. Study Visits: At Weeks 2 and 4: * Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells. * Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. * If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * You will have a neurological exam. At Weeks 6, 12, 18, and 24, and then every 8 weeks: * Samples of CSF from your spinal cord will be collected to check for the presence of cancer cells. * Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. * If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells. * You will have a physical exam (Weeks . * Your performance status will be recorded. * You will be asked about any drugs you may be taking and if you have experienced any side effects. * You will have a neurological exam. * You will complete the questionnaire about your quality of life. * You will have an MRI scan to check the status of the disease. * Urine will be collected to test kidney function and for routine tests. If indicated urine will be collected over a 24 hour period. Every 2 weeks, your blood pressure will be measured. Length of Study: You will be on study for up to 54 weeks (about 1 year). You will be taken off study early if the disease gets worse or you experience intolerable side effects. End-of-Study Visit: If you go off study early, the following tests and procedures will be performed: * You will have a physical exam. * Your performance status will be recorded. * You will have a neurological exam. * Samples of CSF from your spinal cord will be collected to look for the presence of cancer cells. * Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will complete the questionnaire about your quality of life. * If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells. Follow-up Visits: If you do not go off study early, within 4 weeks after the last dose of study drug, every 4 weeks for 3 months, and then every 3 months from then on, you will have follow-up visits. The following tests and procedures will be performed: * You will have a physical exam. * Your performance status will be recorded. * You will have a neurological exam. * Samples of CSF from your spinal will be collected to look for the presence of cancer cells. * Blood (about 3 tablespoons) will be drawn for routine tests and to check your blood's ability to clot normally. You will have an MRI scan to check the status of the disease. -If you already have an Ommaya reservoir tap in place, samples of CSF from your brain will be collected to look for the presence of cancer cells. This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of colon, breast, and lung cancer. Its use for the treatment of cancer that has spread to the meninges of the brain or the spinal cord is investigational. Up to 25 patients will take part in this study. All will be enrolled at MD Anderson.

Titre officielA Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
NCT00924820
Sponsor principalM.D. Anderson Cancer Center
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

20 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies du cerveauNéoplasmes cérébrauxMaladies du système nerveux centralNéoplasmes MéningésNéoplasmes par siteNéoplasmesNéoplasmes du système nerveuxMaladies du système nerveuxNéoplasmes du système nerveux centralCarcinomatose méningée

Critères

11 critères d'inclusion nécessaires pour participer
History of breast cancer, lung cancer or melanoma

Diagnosis of NM as proven either by: 1. positive CSF cytology, or 2. magnetic resonance neuro-imaging, or 3. both

Age >/=18 years.

Routine laboratory studies adequate with bilirubin </= 1.5 x upper limit of normal (ULN), AST < 2.5 x ULN, creatinine <1.0 x ULN, granulocytes >1500, platelets> 75,000; Hb >/= 9.0.

Voir plus de critères

17 critères d'exclusion empêchent la participation
Evidence of active CNS hemorrhage in the brain or tumor lesions

Besides NM, other known CNS disease, except for treated brain metastases(Patients must be at least 1 month out from brain irradiation and have no evidence of progression or hemorrhage at that time, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period). Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery or a combination as deemed appropriate by the treating physician.

2. continued) With respect to irradiation for other purpose (for NM or bone metastases, etc) patients need only 1 week out from the completion of irradiation. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.

Patients with clinically significant cardiovascular disease are excluded 1) Inadequately controlled HTN (SBP > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication). 2) Prior history of hypertensive crisis or hypertensive encephalopathy. 3) New York Heart Association (NYHA) Grade II or greater congestive heart failure.

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

Un seul groupe d'intervention est désigné dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Bevacizumab 10 mg/kg by vein over about 1 hour, every 2 weeks.

Objectifs de l'étude

Objectifs principaux

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

University of Texas MD Anderson Cancer Center

Houston, United StatesOuvrir University of Texas MD Anderson Cancer Center dans Google Maps
Terminé1 Centres d'Étude