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.

Condition	Treatment or Intervention	Phase
Liver Cancer	Drug: thalidomide  Procedure: chemoembolization with doxorubicin/collagen	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with unresectable hepatocellular carcinoma.
• MRI of liver must show discrete tumor nodules. Lesions on angiography must be hypervascular.
• 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

Madeline Peyton      1-212-263-6485 

New York
      Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States; Recruiting

Study ID Numbers:  NCRR-M01RR00096-0958; M01RR00096
Record last reviewed:  January 2004
Record first received:  September 9, 2000
ClinicalTrials.gov Identifier:  NCT00006198
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08