Status:
COMPLETED
A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
Lead Sponsor:
SciClone Pharmaceuticals
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Diagnosis of HCC by:
- 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:
- A new hepatic defect on imaging with an AFP \> 1000 ng/ml, or
- A new hepatic defect on ultrasound or CT with an AFP \< 1000 ng/ml when one of the following is present:
- At least two additional imaging techniques show signs characteristic of HCC, or
- The new hepatic defect has doubled in diameter over time, or
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00082082
Last Update
January 15 2008
Active Locations (5)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
University of Florida
Gainesville, Florida, United States, 32610
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
Columbia University
New York, New York, United States, 10032