VIM
Research type
Research Study
Full title
A randomised controlled phase II trial of oral vinorelbine as second line therapy for patients with malignant pleural mesothelioma
IRAS ID
136117
Contact name
Georgina Gardner
Contact email
Sponsor organisation
University of Leicester
Eudract number
2014-001992-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Malignant pleural mesothelioma (MPM) is an aggressive, frequently drug resistant, and incurable disease that is increasing in incidence in the UK and worldwide. All patients with MPM, subsequently relapse and die following first line therapy, and at present, there is currently no standard treatment available for patients in the second line setting. The vinca alkaloid chemotherapy drug, vinorelbine has shown promising activity in a single arm US trial. However, to date, there has been no randomised evaluation of vinorelbine in mesothelioma, nor has there been any trials which measure the underlying molecular changes of the mesothelioma which could predict vinorelbine efficacy. Studies suggest that vinorelbine requires a gene called BRCA1 (shown to be absent in 38% of cases) in order to induce cell death in mesothelioma.
The VIM trial aims to establish whether treatment with vinorelbine in patients with MPM actually makes them live longer.
200 patients will be randomised (1:2) to receive either active symptom control (ASC) or ASC with vinorelbine. Patients will continue vinorelbine treatment until evidence of disease progression (or unacceptable toxicity to the drug or patient withdrawal). If vinorelbine activity is demonstrated, we will use the results from this trial to inform the design of a future phase III trial.
REC name
Wales REC 3
REC reference
14/WA/1054
Date of REC Opinion
22 Oct 2014
REC opinion
Further Information Favourable Opinion