A Phase II/III Study of Chemotherapy with or without ADI-PEG 20 in Patients with Malignant Pleural Mesothelioma

Full Title

POLARIS2015-003: Randomized, Double-Blind, Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Purpose

Arginine is a nutrient that makes up proteins. Laboratory studies show that an investigational drug called ADI-PEG 20 can break down arginine, destroying cancer cells. In this study, researchers want to see if adding ADI-PEG 20 to chemotherapy for malignant pleural mesothelioma is more effective against the cancer than chemotherapy alone.

Patients will receive chemotherapy with pemetrexed and cisplatin or carboplatin. They will also be randomly assigned to receive ADI-PEG 20 or a placebo. Pemetrexed and cisplatin/carboplatin are given intravenously (by vein), and ADI-PEG 20 is given by injection.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have malignant pleural mesothelioma that has not yet been treated with chemotherapy or immunotherapy.
  • If a patient has had major surgery, at least 4 weeks must pass between the surgery and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Marjorie Zauderer at 646-888-4656.

Protocol

16-1414

Phase

I/II

Investigator

Co-Investigators

Diseases

Locations