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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
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Thalidomide
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00006198     History of Changes
Other Study ID Numbers: NCRR-M01RR00096-0958
M01RR000096 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2004

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Doxorubicin
Thalidomide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors