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Sponsors and Collaborators: |
University of Pittsburgh Biocompatibles UK Ltd |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00877071 |
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: LC Bead loaded with doxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | LC Drug Eluting Bead for Regional Chemoembolization to Downstage Unresectable Hepatocellular Carcinoma (HCC) to Liver Transplantation |
Estimated Enrollment: | 20 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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LC Drug Eluting Bead, Regional Chemoembolization: Experimental
Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
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Drug: LC Bead loaded with doxorubicin
LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation
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LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accepted for treatment of HCC. This novel bead slowly releases the ionically bound chemotherapeutic agent rather than administering a bolus of chemotherapy as is the case with many alternative methods of TACE. Thus, the LC BeadTM offers the potential advantage of less toxicity and prolonged tumor exposure.
This study offers local regional therapy to a defined population of patients beyond transplant criteria as an attempt to downstage them to eligibility for liver transplantation. This study will make an important contribution to understanding the beads' local effect as seen in the explanted livers of those patients who go on to receive a liver transplant. Additionally, we will examine the impact of this novel treatment tool on patients' quality of life.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patient must have at least one tumor lesion that meets both of the following criteria:
The following laboratory parameters
Exclusion Criteria:
Any contraindication for doxorubicin administration:
Excluded therapies and medications, previous and concomitant:
Contact: T. Clark Gamblin, MD, MS | 412-692-2001 | gamblintc@upmc.edu |
United States, Pennsylvania | |
UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | T. Clark Gamblin, MD, MS | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Medical Center ( T. Clark Gamblin, MD, MS ) |
Study ID Numbers: | PRO08070016 |
Study First Received: | April 4, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00877071 History of Changes |
Health Authority: | United States: Institutional Review Board |
Liver Neoplasms Anti-Bacterial Agents Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Doxorubicin Neoplasms, Glandular and Epithelial Carcinoma |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents Carcinoma, Hepatocellular Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Neoplasms, Glandular and Epithelial |