Study of ADI-PEG 20 in Patients With Advanced Melanoma
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via
succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in
subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at
escalating doses weekly for 9 weeks (cycle 1) or 8 weeks (subsequent cycles). The primary
objectives were to the establish the safety, tolerability, and clinical efficacy of ADI-PEG
20. Secondary objectives included evaluation of the metabolic activity by
[18F]-fluorodeoxyglucose positron emission tomography (FDG PET), pharmacodynamics,
correlation of immunogenicity with clinical response, and correlation of argininosuccinate
synthetase (ASS) tumor expression with clinical response.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborators:
Memorial Sloan Kettering Cancer Center New York University School of Medicine NYU Langone Health