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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer Research UK
UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01279967
First received: January 19, 2011
Last updated: October 21, 2014
Last verified: May 2012

January 19, 2011
October 21, 2014
January 2011
January 2015   (final data collection date for primary outcome measure)
progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
To examine progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01279967 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To measure the response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To measure overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To measure time to progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess safety (adverse events) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Clinical Trial of ADI-PEG 20TM in Patients With Malignant Pleural Mesothelioma
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Pleural Mesothelioma
Drug: ADI-PEG 20
36.8mg/m2 based on BSA, weekly treatment for 6 months
  • 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.
    Intervention: Drug: ADI-PEG 20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
March 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01279967
6837, 2006-004592-35
No
Barts & The London NHS Trust
Barts & The London NHS Trust
  • Cancer Research UK
  • UK: Barts Center for Experimental Cancer Medicine (CECM) for Trial Coordination
Principal Investigator: Peter Szlosarek Barts and the London NHS
Barts & The London NHS Trust
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP