The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
polifeprosan 20 with carmustine implant
+ conventional surgery
Enfermedades del Cerebro+8
+ Enfermedades del Sistema Nervioso Central
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2002
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant (Gliadel wafers). Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment. Determine the median, 6-month, 1-year, and 2-year survival of these patients on this regimen. Determine the incidence and severity of cognitive function loss of these patients on this regimen. Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen. OUTLINE: Patients receive up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) implanted in the resected tumor cavity. Patients are followed on day 7 or day of discharge, at 1 month, 3 months, every 3 months for 21 months, and then for survival. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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
DISEASE CHARACTERISTICS: Supratentorial brain metastases for which surgery is recommended Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR Two brain lesions consistent with metastases on MRI scan Lesions must be accessible through a single craniotomy Metastatic lesions clearly distinct from tumor bed of any benign lesions Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion No prior malignant intracranial neoplasm No lesion(s) in the brainstem No open communication of the resection cavity with the ventricle following resection PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic No concurrent hematologic disorders Hepatic No concurrent hepatic disease Renal No concurrent renal disease Cardiovascular No concurrent cardiac disease Pulmonary No concurrent pulmonary disorders Other Not pregnant or nursing Fertile patients must use effective contraception Mini mental score at least 15 No known hypersensitivity to carmustine or Gliadel wafers No other serious concurrent medical illness or infection PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior cranial irradiation Surgery See Disease Characteristics No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma) Other Concurrent systemic therapy allowed
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 11 ubicaciones
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama at Birmingham Comprehensive Cancer Center en Google MapsH. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesEmory University Hospital - Atlanta
Atlanta, United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States