ZOL-A trial
Research type
Research Study
Full title
Zoledronic acid in the management of malignant pleural mesothelioma - a feasibility study
IRAS ID
191013
Contact name
Duneesha de Fonseka
Contact email
Sponsor organisation
North Bristol NHS Trust
Eudract number
2015-004433-26
Duration of Study in the UK
1 years, 5 months, 29 days
Research summary
Malignant mesothelioma is an incurable cancer of the lung lining that usually develops as a result of previous asbestos exposure. It is a terminal disease with an average survival of 9 to 14 months from diagnosis. Treatment proven to prolong life is limited to one form of chemotherapy which only extends life by a few months, on average.
Zoledronic acid (ZA) is a licensed drug that is commonly used for the treatment of bone disease, such as thinning of the bone (osteoporosis) and in cases where bone deposits occur from other cancers. This drug has been is use for a number of years with a good safety record. Animal studies in mice have shown ZA may have a role in the treatment of mesothelioma by slowing the disease. It is not a curative treatment but it may have a role in prolonging life. In animal studies where ZA was used in combination with certain chemotherapy regimens there appears to be an even greater effect.
Unfortunately at this stage the drug is not licenced in mesothelioma, mainly due to the lack of human studies. We propose a preliminary study to assess the practicality of running a trial to establish the role of ZA in patients who have mesothelioma and are undergoing or eligible for chemotherapy. This preliminary study will give us information required to plan a full study that would assess if ZA in addition to chemotherapy would be beneficial to patients or not. In our study, half the patients will have ZA in addition to chemotherapy and the other half will have chemotherapy alone. Neither the patients nor the investigators will know what treatment they have been allocated until the end of the study. In addition, patients who decline chemotherapy will be offered the ZA drug alone.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0105
Date of REC Opinion
4 May 2016
REC opinion
Further Information Favourable Opinion