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Ph 2 / 3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Trial Status: Active

This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.

Inclusion Criteria

  • Histologically proven unresectable MPM of biphasic or sarcomatoid histology
  • Naïve to chemotherapy or immunotherapy
  • ECOG PS 0-1
  • Expected survival of at least 3 months
  • Age 18 years or over (there is no upper age limit)
  • Measurable disease by modified RECIST criteria for MPM for local pleural disease and RECIST 1.1 criteria for metastatic lesions
  • Written (signed and dated) informed consent and must be capable of co-operating with treatment and follow up
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria

  • Radiotherapy (except for palliative reasons) in the previous two weeks before study treatment
  • History of unstable cardiac disease
  • Ongoing toxic manifestations of previous treatments
  • Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery)
  • Major thoracic or abdominal surgery from which the patient has not yet recovered.

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Kim Kelly
Phone: 310-206-8309
San Francisco
UCSF Medical Center-Mount Zion
Status: COMPLETED

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Brett Goldberger
Phone: 410-328-1160

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
Polaris Group

  • Primary ID POLARIS2015-003
  • Secondary IDs NCI-2017-00005
  • Clinicaltrials.gov ID NCT02709512