DIsulfiram REsponse as add-on to ChemoTherapy in recurrent Glioblastoma: A randomized controlled trial - DIRECT

Sahlgrenska University Hospital0 个研究点目标入组 142 人开始时间: 2016年4月18日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•1. A previous diagnosis of glioblastoma (histologically verified) and presenting with a first progression/recurrence documented by MRI.
•2. Indication for treatment with chemotherapeutic alkylating agents (i.e. temozolomide OR lomustine (also known as CCNU) including the so called PCV treatment (procarbazine, CCNU, vincristine)).
•3. Age 18 years or older.
•4. Karnofsky performance status of 60 – 100
•5. Willing to refrain from ingestion of alcoholic beverages
•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 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 15

•1. Earlier treatment for progression
•2. Received radiotherapy within the 3 months before the diagnosis of progression
•3. History of idiopathic seizure disorder, psychosis or schizophrenia.
•4. History of uncontrolled hypertension (i.e. systolic BP > 180 mmHg) or a diagnosis of congestive heart failure
•5. History of active liver disease
•6. History of Wilson's disease or family member with Wilson's disease (unless excluded as a carrier by genetic test).
•7. Use of medications such as metronidazole, warfarin, theophylline, phenytoin, phenobarbital, chlordiazepoxide, imipramine, diazepam, isoniazid, amitriptyline within 14 days prior to the first dose of disulfiram. Of note, lorazepam and oxazepam are not affected by the P450 system and are not contraindicated with disulfiram).
•8. Unfit for participation for any other reason judged by the physician including patients

发起方

Sahlgrenska University Hospital