ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS
chemotherapy
+ suramin
Maladies du cerveau+16
+ Maladies du système nerveux central
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1995
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Estimate the efficacy of suramin in patients with recurrent primary brain tumors as measured by radiographic response, time to progression, and survival. II. Assess the toxic effects of suramin in this patient population. OUTLINE: Single-Agent Chemotherapy. Suramin, SUR, NSC-34936. PROJECTED ACCRUAL: If at least 1 of the first 14 patients experiences at least a partial response, a total of 25 patients will be entered over approximately 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 15 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: Recurrent brain tumor based on one of the following: Tissue diagnosis if there was a prior diagnosis of astrocytoma or oligodendroglioma or if there is a question of radiation necrosis from prior interstitial brachytherapy Metabolic activity in excess of normal cortex measured by 18-fluorodeoxyglucose uptake on PET One of the following histologic types required: Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed glioma Tumor progression required, i.e.: 28% increase in contrast-enhancing area or 50% increase in contrast- enhancing volume over at least 4 weeks Measurable disease required No history, surgical findings, or radiographic signs of intratumoral hemorrhage PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Karnofsky 50%-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 3 times normal No history of bleeding disorder No hepatic disease resulting in hospitalization Renal: Creatinine less than 1.5 mg/dL No renal disease resulting in hospitalization Cardiovascular: No ongoing anticoagulation for deep vein thrombosis (DVT) No residual symptoms from DVT after discontinuation of anticoagulation No cardiac disease resulting in hospitalization Pulmonary: No pulmonary disease resulting in hospitalization Other: No peripheral neuropathy of any etiology HIV negative No pregnant or nursing women Adequate contraception required during and for 12 months following protocol therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for glioblastoma multiforme No more than 1 prior chemotherapy regimen for anaplastic astrocytoma, malignant oligodendroglioma, or malignant mixed glioma At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Completion of 1 course of conventional external radiotherapy required At least 4 weeks since radiotherapy Surgery: Decompressive surgery for clinically suspected increased intracranial pressure performed prior to entry
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 1 site
Department of Neurosurgery - Emory
Atlanta, United StatesOuvrir Department of Neurosurgery - Emory dans Google Maps