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Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006006 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
Liver Cancer |
Drug: recombinant interferon alfa Drug: thalidomide |
Phase II |
MedlinePlus related topics: | Cancer Liver Cancer |
ChemIDplus related topics: | Thalidomide Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression |
Study Start Date: | August 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 29-38 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Regardless of fertility status:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |||||
Mount Sinai School of Medicine | |||||
New York, New York, United States, 10029 | |||||
NYU School of Medicine's Kaplan Comprehensive Cancer Center | |||||
New York, New York, United States, 10016 |
New York University School of Medicine |
National Cancer Institute (NCI) |
Study Chair: | Matthew D. Volm, MD | New York University School of Medicine |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068014, NYU-9938, NCI-101 |
First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006006 |
Health Authority: | United States: Federal Government |
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