ADI-PEG in Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development

Criteria

Inclusion criteria:

• Histologically confirmed metastatic melanoma

• Nonresectable disease

• Measurable or evaluable disease

• Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy

• Recovered from prior surgery

• Karnofsky performance status 70 or higher

• Expected survival of at least 12 weeks

• Bilirubin less than 2.0 mg/dL

• Albumin greater than 3.0 g/dL

• SGOT less than 5 times upper limit of normal (ULN)

• Alkaline phosphatase less than 5 times ULN

• Ammonia less than 55 microg/dL

• Glucose greater than 60 mg/dL

• Amylase less than 1.5 times ULN

• Absolute neutrophil count greater than 1,500/mm3

• Platelet count greater than 100,000/mm3

• Patients must use 2 forms of effective contraception

Exclusion criteria:

• Prior therapy within the past 4 weeks

• Ascites or pleural effusion

• Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease)

• Pregnant or nursing

• Concurrent enrollment in another IND study

• Serious infection requiring antibiotics