A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

January 8, 2008 updated by: SciClone Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SciClone Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 28, 2004

First Submitted That Met QC Criteria

April 29, 2004

First Posted (Estimate)

April 30, 2004

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 8, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ta1-HCC-2K1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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