This is a clinical trial to test the safety and efficacy of the drug thalidomide in
combination with a procedure called chemoembolization in patients with inoperable liver
cancer. Chemoembolization is the process by which chemotherapy is instilled directly into
the blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be
blocked. Chemoembolization consists of two separate procedures. It will be done by infusing
chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by
infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at
various times to allow for these infusions.
The objectives are to investigate the feasibility and potential activity of chronic
administration of thalidomide in patients with unresectable hepatocellular cancer who
receive chemoembolization to predominant tumor masses. The toxicity of thalidomide in these
patients will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic
cytokines such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular
carcinoma, will be collected.
- Patients with unresectable hepatocellular carcinoma.
- MRI of liver must show discrete tumor nodules. Lesions on angiography must be
- Patient must have the following minimum labs: ANC> 1200/mm3; Hemoglobin > 8 mg/dl;
platelets > 50,000 mm3; hepatic transaminases < 5x normal; bilirubin < 3.0 mg/dl; and
creatinine < 1.5 mg/dl.
- ECOG performance status > 2.
- No history of prior chemotherapy or biologic therapy for hepatocellular carcinoma.
- No other history of malignancy other than curatively resected basal cell carcinoma of
the skin or carcinoma in situ of the cervix.
- Patients must not be pregnant or lactating.
- Sexually active men and women of childbearing age must use adequate contraception.
All patients must understand the potential for severe birth defects with thalidomide
and must be able to follow instructions to avoid conception while taking thalidomide