Reference : A phase 1-2, prospective, double blind, randomized study of the safety and efficacy o...
Scientific journals : Article
Human health sciences : Surgery
http://hdl.handle.net/2268/7203
A phase 1-2, prospective, double blind, randomized study of the safety and efficacy of Sulfasalazine for the treatment of progressing malignant gliomas: study protocol of [ISRCTN45828668].
English
Robe, Pierre mailto [Université de Liège - ULg > Département des sciences biomédicales et précliniques > Génétique générale et humaine - Département des sciences biomédicales et précliniques >]
Martin, Didier mailto [Centre Hospitalier Universitaire de Liège - CHU > > Neurochirurgie >]
Albert, Adelin mailto [Université de Liège - ULg > Département des sciences de la santé publique > Informatique médicale et biostatistique - Département de mathématique >]
Deprez, Manuel [Université de Liège - ULg > Département des sciences cliniques > Neuropathologie >]
Chariot, Alain [Centre Hospitalier Universitaire de Liège - CHU > > Chimie médicale >]
Bours, Vincent mailto [Centre Hospitalier Universitaire de Liège - CHU > > Génétique >]
2006
BMC Cancer
BioMed Central
6
29
Yes (verified by ORBi)
International
1471-2407
London
England
[en] Administration, Oral ; Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse effects/therapeutic use ; Brain Neoplasms ; Disease Progression ; Double-Blind Method ; Female ; Glioma ; Humans ; Male ; Middle Aged ; Prognosis ; Prospective Studies ; Sulfasalazine/administration & dosage/adverse effects/therapeutic use ; Survival Analysis ; Treatment Outcome
[en] BACKGROUND: The prognosis of patients suffering from WHO grade 3 and 4 astrocytic glioma remains poor despite surgery, radiation therapy and the use of current chemotherapy regimen. Indeed, the median survival of glioblastoma multiforme (WHO grade 4) patients is at best 14.6 month with only 26.5 percent of the patients still alive after 2 years and the median survival of anaplastic astrocytomas (WHO grade 3) is 19.2 month. Recent evidence suggests that the transcription factor NF-kappaB is constitutively expressed in malignant gliomas and that its inhibition by drugs like Sulfasalazine may block the growth of astrocytic tumors in vitro and in experimental models of malignant gliomas. DESIGN: ULg_GBM_04/1 is a prospective, randomized, double blind single-center phase 1-2 study. A total of twenty patients with progressive malignant glioma despite surgery, radiation therapy and a first line of chemotherapy will be recruited and assigned to four dosage regimen of Sulfasalazine. This medication will be taken orally t.i.d. at a daily dose of 1.5-3-4 or 6 g, continuously until complete remission, evidence of progression or drug intolerance. Primary endpoints are drug safety in the setting of malignant gliomas and tumor response as measured according to MacDonald's criteria. An interim analysis of drug safety will be conducted after the inclusion of ten patients. The complete evaluation of primary endpoints will be conducted two years after the enrollment of the last patient or after the death of the last patient should this occur prematurely. DISCUSSION: The aim of this study is to evaluate the safety and efficacy of Sulfasalazine as a treatment for recurring malignant gliomas. The safety and efficacy of this drug are analyzed as primary endpoints. Overall survival and progression-free survival are secondary endpoint.
http://hdl.handle.net/2268/7203
also: http://hdl.handle.net/2268/7229
10.1186/1471-2407-6-29

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