ADI-PEG in Patients With Metastatic Melanoma

March 24, 2015 updated by: FDA Office of Orphan Products Development

Phase I Testing of ADI-PEG in Metastatic Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life.

In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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
  • Platelet count greater than 100,000/mm3
  • Patients must use 2 forms of effective contraception

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FDA Office of Orphan Products Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

January 24, 2002

First Submitted That Met QC Criteria

January 24, 2002

First Posted (Estimate)

January 25, 2002

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

January 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FD-R-2003-01
  • FD-R-002003-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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