Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by National Center for Research Resources (NCRR).
Recruitment status was  Active, not recruiting
Information provided by:
National Center for Research Resources (NCRR) Identifier:
First received: September 9, 2000
Last updated: June 23, 2005
Last verified: January 2004

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 Intervention Phase
Liver Cancer
Drug: thalidomide
Procedure: chemoembolization with doxorubicin/collagen
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

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Further study details as provided by National Center for Research Resources (NCRR):


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00006198

United States, New York
Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

No publications provided by National Center for Research Resources (NCRR)

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00006198     History of Changes
Other Study ID Numbers: NCRR-M01RR00096-0958  M01RR000096 
Study First Received: September 9, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 11, 2016