A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
This study has been completed.
Information provided by:
First received: April 28, 2004
Last updated: January 8, 2008
Last verified: January 2008
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).
Drug: Thymalfasin (thymosin alpha-1)
Procedure: Trans arterial chemoembolization (TACE)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00082082
|California Pacific Medical Center
|San Francisco, California, United States, 94115 |
|University of Florida
|Gainesville, Florida, United States, 32610 |
|William Beaumont Hospital
|Royal Oak, Michigan, United States, 48073 |
|New York, New York, United States, 10032 |
|Fairfax, Virginia, United States, 22031 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 28, 2004
||January 8, 2008
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Physiological Effects of Drugs