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

November 19, 2014 updated by: Barts & The London NHS Trust

A Randomized Stratified Multicentre Phase II Clinical Trial of Single Agent ADI-PEG 20TM (Pegylated Arginine Deiminase) in Patients With Malignant Pleural Mesothelioma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Brighton, United Kingdom, BN2 5BE
        • The Royal Sussex County Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
      • Hull, United Kingdom, HU8 9HE
        • Hull and East Yorkshire Hospitals NHS Trust,The Princess Royal Hospital
      • London, United Kingdom, EC1 A 7BE
        • Barts and The London NHS, St Bartholomew's Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' Foundation Trust, Guy's Hospital
      • Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester NHS Foundation Trust, Wythenshawe Hospital
      • Southampton, United Kingdom, SO16 6 YD
        • Southampton University Hospitals NHS Trust, Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 18 months
18 months
response rate
Time Frame: 18 months
18 months
time to progression
Time Frame: 18 months
18 months
safety (adverse events)
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

Cancer Research UK
UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination

Investigators

  • Principal Investigator: Peter Szlosarek, Barts and the London NHS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2015

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

January 19, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (ESTIMATE)

January 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6837 (Other Identifier: CTEP)
  • 2006-004592-35 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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