Phase II study of CCNU vs CCNU-dasatinib in recurrent GBM
Research type
Research Study
Full title
Randomised Phase II study of CCNU versus CCNU-dasatinib in patients with recurrent glioblastoma
IRAS ID
29649
Contact name
Anthony J Chalmers
Sponsor organisation
Bristol−Myers Squibb International Corporation
Eudract number
2009-010576-21
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Gliomas are the most frequent brain tumour in adults; the majority are malignant gliomas (also known as glioblastoma multiforme or GBM). With combined treatment of surgery, radiation therapy and chemotherapy, the average survival for patients is approximately 15 months. However with combined treatments, almost all tumours ultimately come back.There are very few drugs available to treat tumours once they have returned. Lomustine (CCNU) has been used since the 1960s but only works in a few patients with this tumour type, so new drugs have to be explored to find more active treatments. The purpose of this study is to assess whether the addition of dasatinib to the standard chemotherapy treatment, (CCNU), has an effect in stopping the progression of a patient??s disease. This will be assessed by measuring the time during which the patient??s disease can be controlled. The study will also determine whether there are genes and/or proteins in tumour samples that can predict how the patient will respond to treatment.This study has two parts; in the first part, 10 patients will receive the combination treatment to investigate the combination of dasatinib with CCNU. This part of the study will not be conducted in the UK.The latter part of the study will consist of half of the patients being treated with CCNU. The other half will be treated with a combination of CCNU and dasatinib. Approximately 98 patients in total are expected to participate in the latter part of the study, with 24 patients from the UK. The spread or growth of tumour will be assessed by regular MRI scans. The study will begin in April 2010 with a recruitment period of 12 months. The research will be funded by Bristol-Myers Squibb and patients will be recruited in the UK from hospitals in England and Scotland.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
09/H0604/111
Date of REC Opinion
3 Dec 2009
REC opinion
Further Information Favourable Opinion