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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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