NCT00029900

Brief Summary

This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2002

First QC Date

January 24, 2002

Last Update Submit

March 24, 2015

Conditions

MelanomaNeoplasm Metastasis

Keywords

Dose-Response Relationship, DrugPolyethylene GlycolArginine Deiminase

Interventions

ADI PEGDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed metastatic melanoma
  • Nonresectable disease
  • Measurable or evaluable disease
  • Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy
  • Recovered from prior surgery
  • Karnofsky performance status 70 or higher
  • Expected survival of at least 12 weeks
  • Bilirubin less than 2.0 mg/dL
  • Albumin greater than 3.0 g/dL
  • SGOT less than 5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 5 times ULN
  • Ammonia less than 55 microg/dL
  • Glucose greater than 60 mg/dL
  • Amylase less than 1.5 times ULN
  • Absolute neutrophil count greater than 1,500/mm3
  • +2 more criteria

You may not qualify if:

  • Prior therapy within the past 4 weeks
  • Ascites or pleural effusion
  • Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease)
  • Pregnant or nursing
  • Concurrent enrollment in another IND study
  • Serious infection requiring antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

ADI PEG20

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

January 24, 2002

First Posted

January 25, 2002

Study Start

September 1, 2001

Study Completion

August 1, 2003

Last Updated

March 25, 2015

Record last verified: 2002-01

Locations

US(1)