Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

Liver Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006198
• Other study ID #: NCRR-M01RR00096-0958
• Secondary ID: M01RR000096
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 9, 2000
• Last updated: June 23, 2005

Study information

• Verified date: January 2004
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer

Intervention

Drug:
• thalidomide

Procedure:
• chemoembolization with doxorubicin/collagen

Locations

Country	Name	City	State
United States	Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,