Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450372
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2007-03-20
Brief Title:
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCCC-2003045 | None | None | None |