Polaris is collaborating with the Ludwig Institute for Cancer Research on a Phase I-II trial to assess the safety and efficacy of ADI-PEG 20 for the treatment of metastatic melanoma.
The Ludwig Center for Cancer Research, the largest international non-profit institute dedicated to understanding and controlling cancer, brings together recognized leaders in many areas of science and oncology to conduct long-term basic and clinical research programs.
This is a Phase I-II, open-label, dose-escalation study of ADI-PEG 20 in patients with advanced melanoma. The purpose of this study is to assess the safety and efficacy of this drug for the treatment of patients with melanoma. Eligible patients receive ADI-PEG 20 intramuscularly once weekly for 9 weeks (Cycle 1). [18F]-FDG PET and CT scans are performed at baseline and at the end of cycle 1 (week 8 and 9 respectively) for assessment of tumor response and changes in tumor metabolic activity induced by ADI-PEG 20. [18F]-FDG PET is also performed on study day 4 for assessment of tumor metabolic activity following the first dose of ADI-PEG 20. Formal assessment of response by RECIST and EORTC functional criteria is based on a comparison of conventional CT scans and [18F]-FDG PET scans done pre-treatment and at the end of Cycle 1 (week 8 and 9).
For more information regarding the Ludwig Institute for Cancer Research (LICR) or the ongoing Phase I-II study click on one of the following links.
LICR: www.licr.org