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Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
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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 |
Biological: recombinant interferon alfa Drug: thalidomide |
Phase II |
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 |
Study Chair: | Matthew D. Volm, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000068014, NYU-9938, NCI-101 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006006 History of Changes |
Health Authority: | United States: Federal Government |
localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Digestive System Neoplasms Immunologic Factors Thalidomide Carcinoma, Hepatocellular Interferons Disease Progression Immunosuppressive Agents |
Angiogenesis Inhibitors Antiviral Agents Recurrence Carcinoma Liver Neoplasms Anti-Bacterial Agents Digestive System Diseases Gastrointestinal Neoplasms Hepatocellular Carcinoma Interferon Alfa-2a |
Anti-Infective Agents Interferon Type I, Recombinant Liver Diseases Immunologic Factors Thalidomide Antineoplastic Agents Physiological Effects of Drugs Liver Neoplasms Anti-Bacterial Agents Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |
Interferon-alpha Digestive System Neoplasms Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Interferon Alfa-2a Leprostatic Agents |