A Pilot Study of Systemically Administered Bevacizumab in Patients With Neoplastic Meningitis (NM)
Bevacizumab
Neoplasias Cerebrales+5
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades del Cerebro
Estudio de Tratamiento
Resumen
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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos 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
University of Texas MD Anderson Cancer Center
Houston, United StatesAbrir University of Texas MD Anderson Cancer Center en Google Maps