ADI-PEG in Patients With Metastatic Melanoma

This study has been completed.

Sponsor:

Information provided by:

FDA Office of Orphan Products Development

ClinicalTrials.gov Identifier:

NCT00029900

First received: January 24, 2002

Last updated: January 31, 2006

Last verified: January 2002

History of Changes

Tracking Information
First Received Date ^ICMJE	January 24, 2002
Last Updated Date	January 31, 2006
Start Date ^ICMJE	September 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00029900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	ADI-PEG in Patients With Metastatic Melanoma
Official Title ^ICMJE	Phase I Testing of ADI-PEG in Metastatic Melanoma
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.
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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Melanoma Neoplasm Metastasis
Intervention ^ICMJE	Drug: ADI PEG
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	15
Completion Date	August 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00029900
Other Study ID Numbers ^ICMJE	FD-R-2003-01, FD-R-002003-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	FDA Office of Orphan Products Development
Verification Date	January 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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