Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
- Determine the clinical response (complete and partial response) in patients with
unresectable metastatic melanoma treated with pegylated arginine deiminase.
- 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
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
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
Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.
Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD
Up to 16 months
Lynn G. Feun, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|