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ADI-PEG in Patients With Metastatic Melanoma

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: January 24, 2002
Last updated: March 24, 2015
Last verified: January 2002
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.

Condition Intervention Phase
Melanoma Neoplasm Metastasis Drug: ADI PEG Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Testing of ADI-PEG in Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 15
Study Start Date: September 2001
Estimated Study Completion Date: August 2003
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00029900

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
FDA Office of Orphan Products Development
  More Information Identifier: NCT00029900     History of Changes
Other Study ID Numbers: FD-R-2003-01
Study First Received: January 24, 2002
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
Dose-Response Relationship, Drug
Polyethylene Glycol
Arginine Deiminase

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes processed this record on August 21, 2017