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A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

Sponsor
SciClone Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00082082
Collaborator
(none)
5
Locations

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Thymalfasin (thymosin alpha-1)
  • Procedure: Trans arterial chemoembolization (TACE)
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. A new hepatic defect on imaging with an AFP > 1000 ng/ml, or

    2. A new hepatic defect on ultrasound or CT with an AFP < 1000 ng/ml when one of the following is present:

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

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

    5. 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

    Locations

    Site City State Country Postal Code
    1 California Pacific Medical Center San Francisco California United States 94115
    2 University of Florida Gainesville Florida United States 32610
    3 William Beaumont Hospital Royal Oak Michigan United States 48073
    4 Columbia University New York New York United States 10032
    5 Metropolitan Research Fairfax Virginia United States 22031

    Sponsors and Collaborators

    • SciClone Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00082082
    Other Study ID Numbers:
    • Ta1-HCC-2K1001
    First Posted:
    Apr 30, 2004
    Last Update Posted:
    Jan 15, 2008
    Last Verified:
    Jan 1, 2008
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Thymalfasin

    Study Results

    No Results Posted as of Jan 15, 2008