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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006016 |
Purpose
RATIONALE: Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Combining thalidomide with chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide and chemoembolization in treating patients who have liver cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: doxorubicin hydrochloride Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer |
| Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure. Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later. Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization. For eligible patients, each lobe is treated separately a second time, in the same sequence, in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must be a candidate for palliative chemoembolization
MRI must show one or more discrete tumor nodules that can be targeted by angiography for chemoembolization
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:
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Alec S. Goldenberg, MD | New York University School of Medicine |
More Information
| Study ID Numbers: | CDR0000068025, NYU-9937, NCI-99 |
| Study First Received: | July 5, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006016 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized unresectable adult primary liver cancer advanced adult primary liver cancer adult primary hepatocellular carcinoma |
|
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 |