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Home > "A" Clinical Trials Conditions > ADI-PEG in Patients With Metastatic Melanoma  ADI-PEG in Patients With Metastatic Melanoma
ADI-PEG in Patients With Metastatic Melanoma
For Condition: Melanoma,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 15
Location and Contact Information:
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting
Additional Information:
Study ID Numbers: FD-R-2003-01; FD-R-002003-01
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029900
Other Neoplasm Metastasis Studies:
1. Immunization of Patients with Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
2. Continuation Study of CpG 7909 in Patients with Stable Disease or Who Have Responded to Therapy for their Malignancies
3. Treatment of Patients with Metastatic Renal Cell Carcinoma with Neutralizing Antibody to Vascular Endothelial Growth Factor (VEGF)
4. Immunization of Patients with Metastatic Melanoma Using DNA Encoding the GP100 Melanoma Antigen
5. Oxaliplatin in Cancer Patients with Impaired Kidney Function
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
ADI-PEG in Patients With Metastatic Melanoma
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