LC Drug Eluting Bead for Treatment of Liver Cancer Which Cannot be Surgically Removed

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: LC Bead loaded with doxorubicin

• Registration Number: NCT00877071
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-04
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2011-05
• Study Completion: 2012-04
• Results First Submitted: 2016-01-08
• Results First Submitted QC: 2016-01-08
• Status Verified: 2016-02
• Results First Posted: 2016-02-08
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

• HCC with gross vascular invasion or extrahepatic disease

• Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), and any cancer curatively treated > 3 years prior to entry is permitted

• Renal failure requiring dialysis

• Child-Pugh B9 or C hepatic impairment

• History of cardiac disease: NYHA class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.

• Active clinically serious infections (> CTCAEv3 grade 2)

• Known history of HIV

• Known central nervous system tumors including metastatic brain disease

• History of organ allograft

• Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

• Allergy to the investigational agents or any agent given in association with this trial.

• Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.

• Uncontrolled hypertension defined as systolic blood pressure > 150mmHg or diastolic blood pressure > 90mmHg

• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months

• Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug

• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug

• Serious non-healing wound, ulcer, or bone fracture

• Any contraindication for doxorubicin administration:

  • serum bilirubin > 3mg/dL
  • WBC < 3000 cells/mm3
  • neutrophil < 1500 cells/mm3
  • cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MRI
  • MUGA scan < 40% ejection fraction

• Any contraindication for hepatic embolization procedures

Excluded therapies and medications, previous and concomitant:

• Prior use of any systemic anti-cancer chemotherapy for HCC
• Prior use of any systemic investigational agents for HCC
• Major surgery within 6 weeks of start of study drug
• Radiotherapy during study or within 3 weeks prior to start of study drug
• Use of biological response modifiers such as granulocyte colony-stimulating factor (G-CSF)within 3 weeks prio to study entry
• Autologous bone marrow transplant or stem cell rescue within four months of study drug initiation
• Concomitant treatment with rifampin or St. John's wort

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LC Drug Eluting Bead, Regional Chemoembolization	LC Bead loaded with doxorubicin	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

Primary Outcome Measures

Name	Time	Method
The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM	36 months	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 both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.

Secondary Outcome Measures

Name	Time	Method
The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria	36 months
Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM	36 months
The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation	36 months

Trial Locations

Locations (1)

UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue; 🇺🇸 Pittsburgh, Pennsylvania, United States