ADI-PEG in Patients With Metastatic Melanoma - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00029900

Purpose

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 I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Testing of ADI-PEG in Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029900

Locations

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00029900 History of Changes
Other Study ID Numbers:	FD-R-2003-01, FD-R-002003-01
Study First Received:	January 24, 2002
Last Updated:	January 31, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Dose-Response Relationship, Drug
Polyethylene Glycol
Arginine Deiminase

Additional relevant MeSH terms:

Neoplasms
Melanoma
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

ClinicalTrials.gov processed this record on February 12, 2012