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

NCT01259024 | Terminated Results DMC

• 1 other identifier: 201108256
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; chemoembolization; transarterial chemoembolization; liver cancer; doxorubicin; drug-eluting beads; LC Bead

Outcome Measures

Primary Outcomes (3)

• To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).

  4-6 weeks after initial treatment, 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.

  Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

• 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.

  4-6 weeks after initial treatment, 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.

  Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

• Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.

  4-6 weeks after initial treatment, 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.

  Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Secondary Outcomes (1)

• To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.

  Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.

Study Arms (1)

doxorubicin-eluting LC Bead

EXPERIMENTAL

transarterial chemoembolization using doxorubicin-eluting LC Beads

Device: transarterial chemoembolization using a drug-eluting bead

Interventions

transarterial chemoembolization using a drug-eluting bead DEVICE

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.

Also known as: TACE, DEB TACE

doxorubicin-eluting LC Bead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital/Washington Univesity School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocelluar carcinoma (HCC). J Surg Oncol. 2010 May 1;101(6):476-80. doi: 10.1002/jso.21522.

  PMID: 20213741 BACKGROUND

• Biselli M, Andreone P, Gramenzi A, Trevisani F, Cursaro C, Rossi C, Ricca Rosellini S, Camma C, Lorenzini S, Stefanini GF, Gasbarrini G, Bernardi M. Transcatheter arterial chemoembolization therapy for patients with hepatocellular carcinoma: a case-controlled study. Clin Gastroenterol Hepatol. 2005 Sep;3(9):918-25. doi: 10.1016/s1542-3565(05)00425-8.

  PMID: 16234031 BACKGROUND

• Malagari K, Pomoni M, Kelekis A, Pomoni A, Dourakis S, Spyridopoulos T, Moschouris H, Emmanouil E, Rizos S, Kelekis D. Prospective randomized comparison of chemoembolization with doxorubicin-eluting beads and bland embolization with BeadBlock for hepatocellular carcinoma. Cardiovasc Intervent Radiol. 2010 Jun;33(3):541-51. doi: 10.1007/s00270-009-9750-0. Epub 2009 Nov 24.

  PMID: 19937027 BACKGROUND

• Namur J, Wassef M, Millot JM, Lewis AL, Manfait M, Laurent A. Drug-eluting beads for liver embolization: concentration of doxorubicin in tissue and in beads in a pig model. J Vasc Interv Radiol. 2010 Feb;21(2):259-67. doi: 10.1016/j.jvir.2009.10.026.

  PMID: 20123210 BACKGROUND

Related Links

• Interventional Radiological Treatment of Hepatocellular Carcinoma
• Drug-Eluting Beads Significantly Reduce Doxorubicin Toxicity in Patients With HCC
• Efficacy of Drug-Eluting Beads in Chemoembolization of Hepatocellular Carcinoma
• Chemoembolization using Drug Eluting Beads is an effective procedure with a favourable pharmacokinetic profile

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

Overall limitation was related to not reaching the target number of participants needed to achieve target power and statistically reliable results due to denial of CMS reimbursement. Majority of this patient population is covered by CMS services.

Results Point of Contact

• Title: Patricia Nieters, RN, BSN, Clinical Research Specialist
• Organization: Washington University

nietersp@wustl.edu

314-362-3371

Study Officials

• Nael E. Saad, M.D.

  Mallinckrodt Institute of Radiology/Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: December 13, 2010
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 15, 2018
• Results First Posted: June 23, 2017

Record last verified: 2018-04

Locations

US (1)