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

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

January 31, 2011

Study Completion Date

February 29, 2012

Conditions
Melanoma (Skin)
Interventions
BIOLOGICAL

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

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

Trial Locations (1)

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

All Listed Sponsors
lead

University of Miami

OTHER

NCT00450372 - Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery | Biotech Hunter | Biotech Hunter