A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma
NCT ID: NCT01279967
Last Updated: 2014-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2011-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Arm A is control arm with best supportive care.
No interventions assigned to this group
B
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
Interventions
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ADI-PEG 20
36.8mg/m2 based on BSA, weekly treatment for 6 months
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
UNKNOWN
Barts & The London NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Peter Szlosarek
Role: PRINCIPAL_INVESTIGATOR
Barts and the London NHS
Locations
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The Royal Sussex County Hospital
Brighton, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust,The Princess Royal Hospital
Hull, , United Kingdom
Barts and The London NHS, St Bartholomew's Hospital
London, , United Kingdom
Guy's and St Thomas' Foundation Trust, Guy's Hospital
London, , United Kingdom
University Hospital of South Manchester NHS Foundation Trust, Wythenshawe Hospital
Manchester, , United Kingdom
Southampton University Hospitals NHS Trust, Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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Szlosarek PW, Luong P, Phillips MM, Baccarini M, Stephen E, Szyszko T, Sheaff MT, Avril N. Metabolic response to pegylated arginine deiminase in mesothelioma with promoter methylation of argininosuccinate synthetase. J Clin Oncol. 2013 Mar 1;31(7):e111-3. doi: 10.1200/JCO.2012.42.1784. Epub 2013 Jan 14. No abstract available.
Szlosarek PW, Steele JP, Nolan L, Gilligan D, Taylor P, Spicer J, Lind M, Mitra S, Shamash J, Phillips MM, Luong P, Payne S, Hillman P, Ellis S, Szyszko T, Dancey G, Butcher L, Beck S, Avril NE, Thomson J, Johnston A, Tomsa M, Lawrence C, Schmid P, Crook T, Wu BW, Bomalaski JS, Lemoine N, Sheaff MT, Rudd RM, Fennell D, Hackshaw A. Arginine Deprivation With Pegylated Arginine Deiminase in Patients With Argininosuccinate Synthetase 1-Deficient Malignant Pleural Mesothelioma: A Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):58-66. doi: 10.1001/jamaoncol.2016.3049.
Related Links
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Related Info
Other Identifiers
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2006-004592-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6837
Identifier Type: -
Identifier Source: org_study_id