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A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma Clinical research trials and A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma. A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma  A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma
A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma
For Condition: Carcinoma, Hepatocellular
Status: Recruiting
Sponsor(s): SciClone Pharmaceuticals ,
Synopsis: The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Signed written informed consent. - Diagnosis of HCC by: 1. Presence of HCC on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of HCC can be determined by: 2. A new hepatic defect on imaging with an AFP > 1000 ng/ml, or 3. A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present: a. At least two additional imaging techniques show signs characteristic of HCC, or b. The new hepatic defect has doubled in diameter over time, or c. The AFP has progressively risen to > 200 ng/ml and triples the mean baseline. - HCC must be unresectable and non-transplantable. - Hematocrit > 30%, platelet count >= 50,000 per microliter, WBC > 2.0 x 109/L, and polymorphonuclear white cell count >= 1.0 x 109/L. - Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/dl. - If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal. Exclusion Criteria: - Concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (Use of oral contraceptives will not exclude an otherwise eligible patient). - Presence of main portal vein thrombosis or hepatic artery malformation. - HCC amenable to treatment by surgical resection or hepatic transplantation. - HIV infection diagnosed by HIV seropositivity and confirmed by Western blot. - Concomitant or prior history of malignancy other than HCC within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix. - Active infectious process that is not of a self-limiting nature. TB and AIDS are examples of infectious processes that are not of a self-limiting nature. - Pregnancy as documented by a urine pregnancy test. Women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study. - Alcohol or intravenous drug abuse within the previous 1 year. - Previous treatment with thymalfasin. - Patients with known hypersensitivity to iodine. - Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.
Total Enrollment:
Location and Contact Information:
Columbia University *Not yet recruiting*
New York City, New York, 10032
United States
Not yet recruiting Lori Rosenthal 212-305-0914
William Beaumont Hospital *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Janet Sherman 248-551-9344
Metropolitan Research *No longer recruiting*
Fairfax, Virginia, 22031
United States
No longer recruiting
University of Florida *Recruiting*
Gainesville, Florida, 32610
United States
Recruiting Joy Peter 352-392-7956
California Pacific Medical Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Ron Frianeza 415-600-3027
Additional Information:
Study ID Numbers: Ta1-HCC-2K1001;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082082
Other Carcinoma, Hepatocellular Studies:
1. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
2. A phase II multicenter uncontrolled trial of BAY 43-9006 in patients with advanced hepatocellular carcinoma
3. A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
4. A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma
5. Treatment of hepatocellular carcinoma with Tetrathiomolybdate
Related Studies:
Other Carcinoma, Hepatocellular Clinical Trials
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A Trial of Thymalfasin in Adult Patients with Hepatocellular Carcinoma
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