Study of ADI-PEG 20 in Patients With Advanced Melanoma

Exclusion Criteria

• •1. Receipt of chemotherapy, immunotherapy, or radiotherapy within 3 weeks prior to first dosing of study agent or lack of recovery from adverse events (AEs) due to agents administered more than 3 weeks earlier. For nitrosoureas, at least 6 weeks must have elapsed.
• •2. Any other malignancy that required concomitant therapy.
• •3. Any medical condition that could have made it difficult for the subject to complete the full course of treatments, at the discretion of the Principal Investigator or co-Principal Investigators.
• •4. Metastatic disease to the central nervous system, unless treated and stable.
• •5. Known human immunodeficiency virus (HIV) positivity.
• •6. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.
• •7. Lack of availability for clinical follow-up assessments.
• •8. Participation in any other clinical trial involving another investigational agent within 3 weeks prior to enrollment.
• •9. Pregnant women or women who were nursing. Women of child-bearing potential and sexually active men must have used appropriate contraception during the course of this study. Women of child-bearing potential must not have been pregnant (negative β human chorionic gonadotropin within 2 weeks of treatment) or nursing during treatment.
• •10. History of seizure disorder.