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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Barts & The London NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Cancer Research UK
UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01279967
First received: January 19, 2011
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Malignant Pleural Mesothelioma
Drug: ADI-PEG 20
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • safety (adverse events) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279967

Contacts
Contact: Marianne Hardy, ADAM Trial Coordinator +44 (0)207 882 8764 adam@qmcr.qmul.ac.uk
Contact: Hanna Nicholas, Clinical Trial Coordinator +44(0) 207 882 8490 h.nicholas@qmul.ac.uk

Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: David Gilligan    +44(0) 1223216555    david.gilligan@addenbrookes.nhs.uk   
Hull and East Yorkshire Hospitals NHS Trust,The Princess Royal Hospital Not yet recruiting
Hull, United Kingdom, HU8 9HE
Contact: Michael Lind    +44(0)1482676736    m.j.lind@hull.ac.uk   
Barts and The London NHS, St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1 A 7BE
Contact: Peter Szlosarek    +44(0)207 882 3559    p.w.szlosarek@qmul.ac.uk   
Guy's and St Thomas' Foundation Trust, Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: James Spicer    +44(0)207 188 4251    james.spicer@kcl.ac.uk   
University Hospital of South Manchester NHS Foundation Trust, Wythenshawe Hospital Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Paul Taylor    +44(0)161 291 2829    paul.taylor@uhsm.nhs.uk   
Southampton University Hospitals NHS Trust, Southampton General Hospital Recruiting
Southampton, United Kingdom, SO16 6 YD
Contact: Luke Nolan , MD    +44 023 8079 6802    Luke.Nolan@SUHT.SWEST.NHS.UK   
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:
No publications provided

Responsible Party: Gerry Leonard, Barts and the London NHS Trust
ClinicalTrials.gov Identifier: NCT01279967     History of Changes
Other Study ID Numbers: 6837, 2006-004592-35
Study First Received: January 19, 2011
Last Updated: May 2, 2012
Health Authority: Medicines & Healthcare products Regulatory Agency (MHRA):United Kingdom

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

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

ClinicalTrials.gov processed this record on September 14, 2014