Spots Global Cancer Trial Database for Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery

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Trial Identification

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

Official Title: Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma

Study ID: NCT00450372

Conditions

Melanoma (Skin)

Interventions

ADI-PEG-20

Pharmacology Studies

Study Description

Brief Summary: RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth. PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.

Detailed Description: OBJECTIVES: Primary: * Determine the clinical response (complete and partial response) in patients with unresectable metastatic melanoma treated with pegylated arginine deiminase. Secondary: * Determine the toxicity profile of this drug in these patients. * Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * Determine the progression-free survival and overall survival of patients treated with this drug. OUTLINE: Patients receive pegylated arginine deiminase intramuscularly once or twice a week in weeks 1-4. Courses repeat every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Blood samples are acquired at baseline and every 2 weeks thereafter for pharmacokinetic and pharmacodynamic studies. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 5 years, and annually thereafter. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.