CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
ADI-PEG-20 +1 morebiological
Likely dose
ADI-PEG-20 160 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00450372
NCT00450372Phase 2Completed
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Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma

University of Miami·interventional·Posted Mar 22, 2007·Updated Feb 8, 2017

In Brief

A Phase 2 clinical trial evaluating ADI-PEG-20 and Pharmacology Studies for Melanoma (Skin). Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma (Skin)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2007
Enrollment StartJun 1, 2004
Primary CompletionJan 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 19.3 years ago

Interventions

ADI-PEG-20biological

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.

Pharmacology Studiesother

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