ADI-PEG in Patients With Metastatic Melanoma

Melanoma Clinical Trial

Official title:

Phase I Testing of ADI-PEG in Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029900
• Other study ID #: FD-R-2003-01
• Secondary ID: FD-R-002003-01
• Status: Completed
• Phase: Phase 1
• First received: January 24, 2002
• Last updated: March 24, 2015
• Start date: September 2001
• Est. completion date: August 2003

Study information

• Verified date: January 2002
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Neoplasm Metastasis

Intervention

Drug:
• ADI PEG

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development

Country where clinical trial is conducted

United States,