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- W2270095792 abstract "8045 Background: Melanoma cells may be sensitive to arginine (Arg) deprivation due to lack of expression of argininosuccinate synthetase (ASS) which is needed to synthesize Arg, a nonessential amino acid in humans, from citrulline (Ctr). ADI-PEG20 lowers plasma Arg levels by catalyzing the conversion of Arg into Ctr. A phase I-II trial of ADI-PEG20 in metastatic melanoma (MM) showed intramuscular (i.m.) weekly doses of 160 IU/m² was well tolerated and resulted in responses in European patients (pts) (JCO 23:7660, 2005). Based on these encouraging results, we performed a phase 2 clinical and pharmacological study of ADI-PEG20 in USA pts with MM. Methods: Pts had weekly i.m. injection of ADI-PEG20 at a starting dose of 160 IU/m². Serum Arg levels were determined q 2 weeks. The dose of ADI-PEG20 was escalated up to 320 IU/m² weekly if Arg levels were still detectable. Tumor evaluation was done q 8 weeks. Tumor samples were assayed for ASS expression using immunohistochemical staining and/or PCR prior to start of therapy and at time of relapse. Results: 17 pts were treated and evaluable. Median age was 69 (range 29- 80). Median performance status was 90 (range 70- 100). Median number of metastatic sites was 2 (range 1- 8). 11 pts had stage M1c and 11 had prior chemotherapy and/or immunotherapy for advanced disease. Responses include partial response (PR) 4 pts (24 %), minor response 2(12 %), mixed response 2 (12%). Duration of PR from start of therapy was 4(+), 6(+), 12, and 16 months. Sites of response include soft tissue/nodal (3 pts) and lung (1 pt). Tumor tissue was available for ASS determination in 12 pts. ASS expression was associated with treatment failure and relapse. Conclusions: This work confirms that ADI-PEG20 appears to be active in MM. Side effects include minor discomfort at the injection site, slight fatigue, and mild elevation of serum uric acid consistent with tumor destruction. ASS expression may correlate with response. This study is continuing to accrue pts. ADI-PEG20 may be beneficial in MM. No significant financial relationships to disclose." @default.
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- W2270095792 date "2006-06-20" @default.
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- W2270095792 title "Phase II study of pegylated arginine deiminase (ADI-PEG20), a novel targeted therapy for melanoma" @default.
- W2270095792 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.8045" @default.
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