Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
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|ClinicalTrials.gov Identifier: NCT00006198|
Recruitment Status : Unknown
Verified January 2004 by National Center for Research Resources (NCRR).
Recruitment status was: Active, not recruiting
First Posted : September 11, 2000
Last Update Posted : June 24, 2005
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 or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: thalidomide Procedure: chemoembolization with doxorubicin/collagen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006198
|United States, New York|
|Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|