The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
polifeprosan 20 with carmustine implant
+ conventional surgery
Maladies du cerveau+9
+ Maladies du système nerveux central
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2002
Date à laquelle le premier participant a commencé l'étude.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.
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.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.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
Critères
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
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 11 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesOuvrir University of Alabama at Birmingham Comprehensive Cancer Center dans 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