A phase I - II, prospective, double blind, randomised study of the safety and efficacy of sulfasalazine for the treatment of progressing malignant gliomas

niversity of Liege, Department of Neurosurgery (Belgium)0 个研究点目标入组 20 人开始时间: 2005年12月15日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Adult patients aged greater than 18 years
•2. With recurrent or progressive World Health Organization (WHO) grade 3 or 4 astrocytic gliomas after surgery
•3. Standard radiation therapy
•4. A first line of conventional chemotherapy (e.g. temozolomide, CCNU or BCNU)
•Recurrence or progression prior to inclusion are based on MacDonald?s criteria. Patients are thoroughly informed about the nature of their disease, suspected prognosis, study background and objectives and potential alternative treatments. This information is provided both orally and in written form, prior to obtaining written informed consent from the patient.

•1. Present with anaplastic oligodendroglioma (WHO grade 3)
•2. Allergy to sulfa drugs
•3. Porphyria
•4. G-6-PD deficiency
•5. Psychiatric disorder deemed incompatible with compliance to the study
•6. Creatinine greater than 15 mg/l
•7. Aspartate aminotransferase (TGO) greater than 200 UI/l
•8. Amylase greater than 150 UI/l
•9. Pregnant or lactating women
•10. Patients may not have received any other experimental medication within 30 days (and at least five drug half-lives) prior to inclusion
•11. Patients cannot concomitantly take mercaptopurine

发起方

niversity of Liege, Department of Neurosurgery (Belgium)