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ADI-PEG in Patients With Metastatic Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on ADI-PEG in Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. ADI-PEG in Patients With Metastatic Melanoma Clinical research trials and ADI-PEG in Patients With Metastatic Melanoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as ADI-PEG in Patients With Metastatic Melanoma. ADI-PEG in Patients With Metastatic Melanoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a ADI-PEG in Patients With Metastatic Melanoma clinical trial. Human subjects often receive the most effective healthcare possible for their ADI-PEG in Patients With Metastatic Melanoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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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 Melanoma Studies:
1. A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients with Primary and Metastatic Brain Tumors
2. ABX-EGF in Combination with Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
3. Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
4. Phase I Study of Noni in Cancer Patients
5. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
ADI-PEG in Patients With Metastatic Melanoma
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