This trial is active, not recruiting.

Condition malignant pleural mesothelioma
Treatment adi-peg 20
Phase phase 2
Sponsor Barts & The London NHS Trust
Collaborator Cancer Research UK
Start date January 2011
End date January 2015
Trial size 70 participants
Trial identifier NCT01279967, 2006-004592-35, 6837


To examine whether the arginine depleting drug, ADI-PEG 20, might be effective as a targeted therapy in patients with ASS-negative malignant pleural mesothelioma.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
Arm A is control arm with best supportive care.
Arm B is the treatment arm with best supportive care plus ADI-PEG20.
adi-peg 20
36.8mg/m2 based on BSA, weekly treatment for 6 months

Primary Outcomes

progression-free survival
time frame: 18 months

Secondary Outcomes

response rate
time frame: 18 months
overall survival
time frame: 18 months
time to progression
time frame: 18 months
safety (adverse events)
time frame: 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 lab confirmation is required before randomization 3. Performance status ECOG ≤ 1. Life expectancy should be greater than 3 months 4. Chemo-naive patients OR, Patients who have been previously treated with platinum-based combination chemotherapy with progressive disease at entry. In the event of a baseline diagnostic ASS-positive test, a repeat biopsy confirming loss of ASS expression will be required post platinum-based combination chemotherapy, with at least a 4 week interval from the last treatment episode. 5. CT evaluable disease by modified RECIST criteria 6. Adequate bone marrow function, or supported through treatment: - Haemoglobin 10g/dl or greater. - White cell count 2 x 109/L or greater, neutrophil count 1.5 x 109/L or greater - Platelets 75 x 109 /L or greater. 7. Adequate hepatic function (AST and ALT < 3 x upper limit of normal; bilirubin < 1.5 x upper limit of normal) 8. Creatinine clearance >30ml/min 9. Able to give written informed consent to participate Exclusion Criteria: 1. Participation in another clinical trial using an investigational agent 2. Patients with surgically resectable disease 3. Recurrent pleural effusion (not pleurodesed) 4. Receipt of extensive radiation (hemi-thorax) therapy within 6 weeks before enrollment. Radiation to chest port sites following thoracotomy is permitted 5. 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 6. Symptomatic or known brain or leptomeningeal metastases 7. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment 8. 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 9. Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection, uncontrolled gout) or psychiatric illness likely to interfere with participation in this clinical study 10. History of seizures 11. 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. All patients enrolled on the study must agree to use acceptable birth control measures whilst on the study; using both barrier and hormonal methods. Patients that are surgically sterile are also eligible to participate in this study 12. Females must not be breastfeeding 13. Prior exposure to ADI-PEG 20 14. Preplanned surgery or procedures that would interfere with the study protocol 15. Allergy to pegylated products 16. Exposure to another investigational drug within 4 weeks prior to start of study treatment

Additional Information

Official title A Randomized Stratified Multicentre Phase II Clinical Trial of Single Agent ADI-PEG 20TM (Pegylated Arginine Deiminase) in Patients With Malignant Pleural Mesothelioma
Principal investigator Peter Szlosarek
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Barts & The London NHS Trust.