ADI-PEG in Patients With Metastatic Melanoma

Completed · Phase 1

Conditions studied: Melanoma, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00029900

Run by

FDA Office of Orphan Products Development

People needed

15

Starts

2001-09-01

Expected to finish

2003-08-01

Last updated by the study team

2015-03-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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