Melanoma (Skin) Clinical Trial
Official title:
Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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