|
Testing of ADI-PEG in Hepatocellular Carcinoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Testing of ADI-PEG in Hepatocellular Carcinoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Testing of ADI-PEG in Hepatocellular Carcinoma Clinical research trials and Testing of ADI-PEG in Hepatocellular Carcinoma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Testing of ADI-PEG in Hepatocellular Carcinoma. Testing of ADI-PEG in Hepatocellular Carcinoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Testing of ADI-PEG in Hepatocellular Carcinoma clinical trial. Test subjects typically obtain the finest healthcare available for their Testing of ADI-PEG in Hepatocellular Carcinoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Testing of ADI-PEG in Hepatocellular Carcinoma  Testing of ADI-PEG in Hepatocellular Carcinoma
Testing of ADI-PEG in Hepatocellular Carcinoma
For Condition: Carcinoma, Hepatocellular
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see Rogers 1994). Therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable HCC. The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986). However, ADI is only found in microbes and not in humans. ADI is therefore, highly immunogenic and has a short serum half-life following injection. These potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to argininedeiminase and termed this drug ADI-PEG 20. ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20 eliminates all detectable arginine from the circulation for at least 7 days. This treatment appears to be well tolerated. The purpose of this study is to determine the efficacy of this treatment in patients with HCC. Efficacy is a primary end point of this study. No patients will recieve placebo.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Histologically confirmed diagnosis of hepatocellular carcinoma. - Non-resectable disease. - Progressive disease after chemotherapy, radiotherapy, surgery or immuno-therapy, and be no longer responding to such therapy, or have refused such therapy. - Been off previous treatment for at least 4 weeks. - Been fully recovered from all prior surgery. - Age of > 18 years. - Karnofsky performance status of > 70. - Expected survival of > 12 weeks. - Total bilirubin < 3.0 mg/dl. - Serum albumin > 3.0 g/dl. - Serum SGOT < 5 x upper limit of normal. - Serum alkaline phosphatase < 5 x upper limit of normal. - Serum ammonia < 55 mg/dl. - Serum glucose > 60 mg/dl. - Serum amylase < 1.5 x upper limit of normal. - ANC > 1,500 / ml. - Platelets > 100,000 / ml. - Female subjects of childbearing age and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum HCG pregnancy test must be negative before entry into the study. - Informed consent. - Not be enrolled in other IND studies. - Disease must be measurable or evaluable.
Total Enrollment: 34
Location and Contact Information:
MD Anderson Cancer center *Recruiting*
Houston, Texas,
United States
Recruiting Steve Curley 713-794-4957
Additional Information:
Study ID Numbers: 2206;
Study Start Date: September 2002
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056992
Other Carcinoma, Hepatocellular Studies:
1. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
2. A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
3. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer
4. A phase II multicenter uncontrolled trial of BAY 43-9006 in patients with advanced hepatocellular carcinoma
5. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
Related Studies:
Other Carcinoma, Hepatocellular Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Testing of ADI-PEG in Hepatocellular Carcinoma
|
|
|
|
|
|
|
|
