Clinical trial NCT00082082: A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: SciClone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-04-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
Study officials:
References: