Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

This study is ongoing, but not recruiting participants.

First Received: September 9, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006198

Purpose

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Thalidomide Doxorubicin Doxorubicin hydrochloride Myocet

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	NCRR-M01RR00096-0958, M01RR00096
Study First Received:	September 9, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006198 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Thalidomide
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Immunosuppressive Agents

Doxorubicin
Pharmacologic Actions
Liver Neoplasms
Anti-Bacterial Agents
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009