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A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma (ADAM)

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ClinicalTrials.gov Identifier: NCT01279967
Recruitment Status : Unknown
Verified May 2012 by Barts & The London NHS Trust.
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2011
Last Update Posted : November 20, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: ADI-PEG 20 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: A
Arm A is control arm with best supportive care.
Experimental: B
Arm B is the treatment arm with best supportive care plus ADI-PEG20.
Drug: ADI-PEG 20
36.8mg/m2 based on BSA, weekly treatment for 6 months


Outcome Measures

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: 18 months ]
  2. overall survival [ Time Frame: 18 months ]
  3. time to progression [ Time Frame: 18 months ]
  4. safety (adverse events) [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279967


Locations
United Kingdom
The Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Hull and East Yorkshire Hospitals NHS Trust,The Princess Royal Hospital
Hull, United Kingdom, HU8 9HE
Barts and The London NHS, St Bartholomew's Hospital
London, United Kingdom, EC1 A 7BE
Guy's and St Thomas' Foundation Trust, Guy's Hospital
London, United Kingdom, SE1 9RT
University Hospital of South Manchester NHS Foundation Trust, Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Southampton University Hospitals NHS Trust, Southampton General Hospital
Southampton, United Kingdom, SO16 6 YD
Sponsors and Collaborators
Barts & The London NHS Trust
Cancer Research UK
UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
Investigators
Principal Investigator: Peter Szlosarek Barts and the London NHS
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01279967     History of Changes
Other Study ID Numbers: 6837
2006-004592-35 ( EudraCT Number )
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: May 2012

Keywords provided by Barts & The London NHS Trust:
Pleural Mesothelioma
ADI-PEG 20

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial