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

NCT00877071 | Completed Phase 2 Results DMC

• 1 other identifier: PRO08070016
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM

  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.

  36 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Drug: LC Bead loaded with doxorubicin

Interventions

LC Bead loaded with doxorubicin DRUG

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

Also known as: LC Bead

LC Drug Eluting Bead, Regional Chemoembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (1)

UPMC Liver Cancer Center, Montefiore 7 South, 3459 Fifth Avenue

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. David Geller
• Organization: University of Pittsburgh Medical Center

gellerda@upmc.edu

412-692-2001

Study Officials

• David A Geller, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Geller, PI

Study Record Dates

• First Submitted: April 4, 2009
• First Posted: April 7, 2009
• Study Start: November 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 11, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-02

Locations

US (1)