Malignant pleural mesothelioma Cancer Mesothelioma
Conditions
Interventions
Patients with ASS1-negative mesothelioma confirmed by immunohistochemistry will be randomised as follows:
Arm A: Best supportive care (n = 21)
Arm B: ADI-PEG 20 and best supportive care (n = 42)
Ass
Sponsors
Barts and The London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 years and older (there is no upper age limit) 2. Histopathological evidence of ASS-negative MPM. All biopsies will be reviewed for ASS expression using immunohistochemistry (central review by Dr Michael Sheaff, Institute of Cell and Molecular Sciences, Barts and The London School of Medicine) 3. Performance status Eastern Cooperative Oncology Group (ECOG) 0 - 1 4. No prior systemic chemotherapy 5. Computed tomography (CT) evaluable disease by modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria 6. Adequate haematological status (haemoglobin 10 g/dl or greater; white cell count 2 x 10^9/L or greater, neutrophil count 1.5 x 10^9/L or greater; platelets 100 x 10^9 /L or greater) 7. Adequate hepatic function (bilirubin less than 1.5 x upper limit of normal; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 x upper limit of normal) 8. Creatinine clearance greater than 30 ml/min 9. Willing to give written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Any of the above inclusion criteria are not met 2. Enrolment in another clinical trial 3. Patients with surgically resectable disease 4. Recurrent pleural effusion (not pleurodesed) 5. Receipt of extensive radiation (hemi-thorax) therapy within 6 weeks before enrolment. Radiation to chest port sites following thoracotomy is permitted. 6. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years, or the tumour was a non-melanoma skin tumour or in-situ cervix carcinoma 7. Symptomatic or known brain or leptomeningeal metastases 8. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment 9. New York Heart Association (NYHA) class III or IV heart failure (attachment 10, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 10. Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection) or psychiatric illness likely to interfere with participation in this clinical study 11. History of seizures 12. Patients of child-bearing age must not become pregnant. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Acceptable birth control measures whilst on the study include barrier and hormonal methods; patients that are surgically sterile are also eligible to participate in this study. 13. Females must not be breastfeeding 14. Prior exposure to ADI-PEG 20 15. Pre-planned surgery or procedures that would interfere with the study protocol 16. Allergy to pegylated products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, measured from the date of randomisation until the date of progression or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate, measured by image assessment every two months 2. Median overall survival 3. Toxicity, measured continuously throughout the study | — |
Countries
United Kingdom
Outcome results
None listed