PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
carmustine
+ conventional surgery
Maladies du cerveau+18
+ Maladies du système nerveux central
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma. OUTLINE: This is a dose escalation study. All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity. Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study. Patients are followed 3, 6, and 12 months after implantation. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
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: Pathologically confirmed recurrent malignant glioma for which surgery is indicated Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: Creatinine less than 1.5 times normal BUN less than 2.5 times normal Protein no greater than 3 g/dL No gross hematuria Other: No hypersensitivity to nitrosoureas Not pregnant Fertile patients must use effective contraception No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy during first 8 weeks of study Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: Not specified Radiotherapy: Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: Prior cytoreductive surgery for supratentorial brain tumor required Biopsy alone not sufficient Other: No concurrent investigational therapy during first 8 weeks of study
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 9 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