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

Phase 2

Completed

• Conditions: Melanoma (Skin)
• Interventions: Biological: ADI-PEG-20; Other: Pharmacology Studies

• Registration Number: NCT00450372
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-22
• Primary Completion: 2011-01
• Study Completion: 2012-02
• Results First Submitted: 2013-02-01
• Results First Submitted QC: 2013-03-14
• Results First Posted: 2013-05-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADI-PEG 20	ADI-PEG-20	-
ADI-PEG 20	Pharmacology Studies	-

Primary Outcome Measures

Name	Time	Method
Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.	Up to 16 months	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

Secondary Outcome Measures

Name	Time	Method
Median Time to Progression	Up to 16 months	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
Median Overall Survival	Up to 16 months	Overall survival will be estimated using the product-limit method of Kaplan \& Meier.

Trial Locations

Locations (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami; 🇺🇸 Miami, Florida, United States