A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082082
• Other study ID #: Ta1-HCC-2K1001
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2004
• Last updated: January 8, 2008

Study information

• Verified date: January 2008
• Source: SciClone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 non-surgical hepatocellular carcinoma (HCC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

1. At least two additional imaging techniques show signs characteristic of HCC, or

2. The new hepatic defect has doubled in diameter over time, or

3. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Thymalfasin (thymosin alpha-1)

Procedure:
• Trans arterial chemoembolization (TACE)

Locations

Country	Name	City	State
United States	Metropolitan Research	Fairfax	Virginia
United States	University of Florida	Gainesville	Florida
United States	Columbia University	New York	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
SciClone Pharmaceuticals

Country where clinical trial is conducted

United States,