The LC Bead Trial; Transarterial Chemoembolization of Hepatocellular Carcinoma (HCC)With a Drug-eluting Bead

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01259024
First received: November 3, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

This study involves the combined use of the FDA approved device, LC Bead and the FDA approved drug, Doxorubicin for the treatment of primary hepatocellular carcinoma (HCC). The current indication of the LC Bead is for the embolization of hypervascular tumors and arteriovenous malformations. The study is designed to establish if drug eluting beads are more effective and less toxic than standard chemoembolization treatment.


Condition Intervention
Hepatocellular Carcinoma
Device: transarterial chemoembolization using a drug-eluting bead

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepatic Arterial Embolization of Hepatocellular Carcinoma With a Doxorubicin Eluting Bead

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To collect data on patients with hepatocellular carcinoma (HCC) being treated with chemoembolization with doxorubicin eluting beads (DEB). [ Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study. ] [ Designated as safety issue: No ]
    4-6 weeks after initial treament, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.

  • Determine efficacy (based on whether the study is positive or negative) of the embolization with the LC Bead in treatment of HCC with imaging outcomes using modified RECIST and EASL criteria. [ Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study. ] [ Designated as safety issue: No ]
    4-6 weeks after initial treament, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.

  • Monitor safety after treatment of DEB by measuring liver function tests and assessing performance status. [ Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study. ] [ Designated as safety issue: Yes ]
    4-6 weeks after initial treament, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.


Secondary Outcome Measures:
  • To track survival following treatment with DEB to confirm that any gains in response are associated with an increase in survival. [ Time Frame: Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study. ] [ Designated as safety issue: No ]
    4-6 weeks after initial treament, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.


Estimated Enrollment: 5
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: transarterial chemoembolization using a drug-eluting bead
    Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization.
    Other Names:
    • TACE
    • DEB TACE
Detailed Description:

Patients will be given IV fluids and premedication with 500 mg metronidazole, 10 mg dexamethasone, and 8 mg ondansetron to prevent infection, limit pain and nausea. The femoral artery will be accessed and a catheter advanced into the superior mesenteric artery. Positioning of all catheters will be confirmed by injection of radiographic contrast material. Superior mesenteric angiography will be performed with images obtained through the portal venous phase to confirm patency and flow direction of the portal vein and determine the presence of aberrant supply to the right lobe of the liver by the superior mesenteric artery. The catheter will then be advanced into the celiac artery. Celiac angiography will be performed to determine remainder of the hepatic arterial anatomy. Selection of the tumor bearing artery will then be performed with a microcatheter which is advanced through the catheter in the celiac artery origin. Selection will be guided by fluoroscopy and will be at the lobar level or peripherally in all cases. Once the feeding vessel has been selected and confirmed by contrast injection, the physician will initiate embolization with LC Beads. Up to two vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared. The LC Beads will be mixed with radiographic contrast to ensure fluoroscopic visibility during injection. Under careful fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery reaches stasis prior to administration of both vials, the residual volume of LC Beads will be noted on the surgical report form. If after administration of the DEB, there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization. After confirming that the artery is appropriately treated, all catheters and guidewires will be removed from the femoral artery and hemostasis obtained.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18
  • Patent main portal vein with hepatopetal flow
  • Bilirubin less than or equal to 2.5 mg/dl, albumin >2.8g/dl, alkaline phosphatase <630IU/L, AST <235IU/L, ALT <265IU/L, INR <2.0, PTT <40sec., absolute neutrophil count >1K/cumm, platelet count >100K/cumm
  • No encephalopathy
  • No previous biliary ductal intervention
  • Child A status
  • Confirmation of Hepatocellular Carcinoma (through biopsy or radiological exam)
  • Unresectable HCC and ineligible for possible curative therapies
  • Normal ECG with QT <480 msec within the previous 2 months
  • Normal MUGA scan within the previous 2 months
  • Measureable disease per the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Subject is competent and willing to provide written informed consent in order to participate in the study

Exclusion Criteria:

  • Thrombosis or hepatofugal flow in the main portal vein; presence of a large shunt which in the operator's opinion precludes embolization
  • Replacement of greater than 50% of the liver parenchyma by tumor
  • Bilirubin greater than or equal to 2.6 mg/dl
  • ECOG performance status of 2 or greater
  • Previous liver directed therapy
  • Previous biliary intervention (excluding cholecystectomy)
  • Allergy to iodinated contrast used for angiography
  • Elevated creatinine greater than or equal to 1.8 mg/dl
  • Women who are pregnant or nursing
  • Patients in which any of the following are contraindicated: 1)the use of doxorubicin, 2)MRI or CT scans, 3) Hepatic embolization procedures
  • Patients with active bacterial or fungal infection that is deemed to be clinically significant by the investigator
  • Patients with cardiac disease, including congestive heart failure, recent myocardial infarction, or uncontrolled arrhythmias
  • Non-English speaking patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259024

Contacts
Contact: Patricia M Nieters, RN, BSN 314-362-3371 nietersp@mir.wustl.edu

Locations
United States, Missouri
Barnes-Jewish Hospital/Washington Univesity School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Patricia M Nieters, RN, BSN    314-362-3371    nietersp@mir.wustl.edu   
Principal Investigator: Nael E. Saad, MD         
Sub-Investigator: Michael Darcy, MD         
Sub-Investigator: Jennifer Gould, MD         
Sub-Investigator: Seung K Kim, MD         
Sub-Investigator: Naganthan Mani, MD         
Sub-Investigator: Daryl Zuckerman, MD         
Sub-Investigator: William Chapman, MD         
Sub-Investigator: Maria B Majella-Doyle, MD         
Sub-Investigator: Christopher Anderson, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Nael E. Saad, M.D. Mallinckrodt Institute of Radiology/Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01259024     History of Changes
Other Study ID Numbers: 201108256
Study First Received: November 3, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
hepatocellular carcinoma
chemoembolization
transarterial chemoembolization
liver cancer
doxorubicin
drug-eluting beads
LC Bead

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014