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

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Qué se está evaluando

Bevacizumab

Medicamento
Quiénes están siendo reclutados

Neoplasias Cerebrales+5

+ Enfermedades del Sistema Nervioso Central

+ Enfermedades del Cerebro

A partir de 18 años
+28 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1 & 2
Intervencional
Inicio del estudio: junio de 2009
Ver detalles del protocolo

Resumen

Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de junio de 2009

Fecha en la que se inscribió al primer participante.

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.

Título OficialA Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
NCT00924820
Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 20 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Neoplasias CerebralesEnfermedades del Sistema Nervioso CentralEnfermedades del CerebroNeoplasias MeningeasNeoplasiasNeoplasias por SitioEnfermedades del sistema nerviosoNeoplasmas del Sistema Nervioso

Criterios

11 criterios de inclusión requeridos para participar
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.

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17 criterios de exclusión impiden participar
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.

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

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

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

University of Texas MD Anderson Cancer Center

Houston, United StatesAbrir University of Texas MD Anderson Cancer Center en Google Maps
Completado1 Centros de Estudio