Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
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.
Other: Pharmacology Studies
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma|
- Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor. [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]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
- Median Overall Survival [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]Overall survival will be estimated using the product-limit method of Kaplan & Meier.
- Median Time to Progression [ Time Frame: Up to 16 months ] [ Designated as safety issue: No ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
|Study Start Date:||June 2004|
|Study Completion Date:||February 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Experimental: ADI-PEG 20||
There will be 6 cycles planned, each consisting of 4 weeks. During each cycle subjects will receive injections on days 1, 8, 15, and 22 + 2 days. All subjects may begin treatment with 160 IU/m2 on a weekly basis.
Other Name: Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)Other: Pharmacology Studies
tissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450372
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Lynn G. Feun, MD||University of Miami Sylvester Comprehensive Cancer Center|