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

Recruitment status:
Not recruiting
Primary Sponsor:
Barts & The London NHS Trust
Recruitment countries:
United Kingdom
Health condition studied:
Malignant Pleural Mesothelioma
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: ADI-PEG 20
Key inclusion and exclusion 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
  • Age minimum:  18 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
progression-free survival
Secondary outcomes:
overall survival
response rate
safety (adverse events)
time to progression
Target sample size:
70
Study type:
Interventional
Study design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Contacts:
  • Name:   Peter Szlosarek
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Barts and the London NHS

Technical details

Scientific title:
A Randomized Stratified Multicentre Phase II Clinical Trial of Single Agent ADI-PEG 20TM (Pegylated Arginine Deiminase) in Patients With Malignant Pleural Mesothelioma
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Cancer Research UK
UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
Main ID:
NCT01279967
Secondary ID:
2006-004592-35
6837
Register:
ClinicalTrials.gov
Date of registration:
19/01/2011
Date of first enrollment:
January 2011
Last refreshed:
19 February 2015

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