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Clinical Trial Summary

Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may kill more tumor cells.


Clinical Trial Description

OBJECTIVES:

I. Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma.

II. Evaluate the toxicity of thalidomide in these patients. III. Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00006006
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date August 2000

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