Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00450372|
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : May 1, 2013
Last Update Posted : February 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: ADI-PEG-20 Other: Pharmacology Studies||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2012|
|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
- Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor. [ Time Frame: 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
- Median Overall Survival [ Time Frame: Up to 16 months ]Overall survival will be estimated using the product-limit method of Kaplan & Meier.
- Median Time to Progression [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|