A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High Grade Malignant Glioma - ASPECT

Ark Therapeutics Limited0 个研究点目标入组 250 人开始时间: 2006年2月20日最近更新: 2012年3月19日

适应症

试验速览

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•1.Patients who have a supratentorial primary glioblastoma multifornae [GBM]. The diagnosis is based on radiological and clinical grounds
•2.Male or female patients who are between 18 and 70 years of age (male and female patients of childbearing potential must agree to use an acceptable method of contraception for the period that they are receiving GCV. Male patients must continue to use an acceptable method of contraception for 90 days thereafter)
•3.Karnofsky score = 70
•4.Patients who signed the informed consent form
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Patients with recurrent gliomas
•2.Patients with a medical or psychiatric condition that compromises their ability to participate in the study.
•3.Patients who have received an investigational drug within 30 days or five half-lives of study enrollment
•4.Patients with known or suspected drug or alcohol abuse in the past 6 months
•5.Patients who are known to be human immunodeficiency virus (HIV)-positive
•6.Patients with other significant disease, including renal or liver diseasePatients who are allergic to GCV or for whom GCV is contra-indicated
•8.Patients with bihemispheric or multifocal tumours
•9.Patients who receive chemotherapy within six weeks prior to randomisation
•10.Pregnant or lactating females

发起方

Ark Therapeutics Limited