ADAM (Arginine Deiminase And Mesothelioma)
Research type
Research Study
Full title
A Randomised Stratified Multicentre Phase II Clinical Trial of Single-Agent ADI-PEG 20 (Pegylated Arginine Deiminase) in Patients with Malignant Pleural Mesothelioma.
IRAS ID
28434
Contact name
Peter Szlosarek
Eudract number
2006-004592-35
ISRCTN Number
CCT-NAPN-19113
Research summary
Malignant pleural mesothelioma (MPM) is a type of lung cancer that's rapidly lethal and usually associated with asbestos exposure. Both normal and the lung tumour cells are dependent on the nutrient arginine and require a specific protein called arginosuccinate synthetase (ASS) to help produce arginine. However, some MPM tumours lack ASS and are therefore unable to make arginine. Treating these tumours with Pegylated arginine deiminase (ADI-PEG 20), which destroys arginine, results in arginine starvation and ultimately death of these tumour cells, sparing normal cells.The proposed phase II trial aims to estimate the efficacy of ADI-PEG 20 at controlling tumour growth in patients whose tumours are unable to make arginine and who have not as yet received chemotherapy for their disease.Twenty one patients will be randomly assigned to receive best supportive care (BSC) and 42 patients will receive BSC and weekly doses of ADI-PEG20 for 6 months. Blood counts and biochemical measurements of organ function will be measured weekly for patients receiving ADI-PEG and monthly for those receiving BSC only. Tumour response will be measured using CT and PET CT scans. Patients who show no response or tumour progression will be offered alternative treatment according to local policy. Blood and Biochemical tests and tumour material will also be taken for research purposes, to taken to assess the effects of ADI-PEG and develop markers for this disease.
REC name
London - South East Research Ethics Committee
REC reference
09/H1102/107
Date of REC Opinion
30 Dec 2009
REC opinion
Further Information Favourable Opinion