A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00082082
First received: April 28, 2004
Last updated: January 8, 2008
Last verified: January 2008
  Purpose

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).


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Thymalfasin (thymosin alpha-1)
Procedure: Trans arterial chemoembolization (TACE)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

      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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082082

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
SciClone Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00082082     History of Changes
Other Study ID Numbers: Ta1-HCC-2K1001
Study First Received: April 28, 2004
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Thymalfasin
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014