Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed metastatic melanoma, meeting any of the following criteria:
• •* Progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy
• •* No longer responding to standard therapy OR have refused standard therapy
• •Unresectable disease
• •Measurable or evaluable disease
• •No clinical ascites
• •No symptomatic pleural effusion
• •PATIENT CHARACTERISTICS:
• •Life expectancy ≥ 12 weeks
• •Karnofsky performance status 70-100%
• •Bilirubin ≤ 3.0 mg/dL
• •Albumin ≥ 3.0 g/dL
• •Alkaline phosphatase \< 5 times upper limit of normal (ULN)
• •Serum glucose \> 60 mg/dL
• •Amylase \< 1.5 times ULN
• •Absolute neutrophil count \> 1,500/mm³
• •Platelet count \> 100,000/mm³
• •No New York Heart Association class III-IV heart failure
• •No serious infection requiring treatment with antibiotics
• •No known allergy to E. coli drug products (e.g., sargramostim \[GM-CSF\])
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use 2 forms of effective contraception
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •At least 4 weeks since prior anticancer therapy
• •At least 4 weeks since prior surgery and recovered
• •No concurrent participation in another investigational drug study