An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
I. Determine the feasibility and potential activity of thalidomide in patients with
unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant
II. Determine the toxicity of this regimen of these patients. III. Determine the overall
survival of patients treated with this regimen. IV. Determine the serum levels of vascular
endothelial growth factor, basic fibroblast growth factor, and tumor necrosis factor alpha
in patients treated with this regimen.
Patients receive oral thalidomide daily beginning 4 weeks before the first planned
chemoembolization procedure. Thalidomide administration is stopped 24 hours before each
chemoembolization procedure, and then restarted at 24 hours after completion of each
procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever
occurs later. Thalidomide treatment continues in the absence of disease progression or
Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as
a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic
guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate
embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of
the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of
the last chemoembolization. For eligible patients, each lobe is treated separately a second
time, in the same sequence, in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 18 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The survival distribution will be estimated using the Kaplan-Meier method, with corresponding 95% confidence intervals.
Up to 18 months
New York University Langone Medical Center
United States: Food and Drug Administration
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