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Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

doxorubicin, superabsorbent polymer microspheres, embolotherapy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring chemoembolization, drug eluting microsphere, hepato, embolotherapy, downstage

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

Sites / Locations

Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

50mg dose loading per vial of doxorubicin

75mg dose loading per vial of doxorubicin

Arm Description

Outcomes

Primary Outcome Measures

Histopathological correlation with surgically resected tumor

Secondary Outcome Measures

Dose limiting toxicities

serum doxorubicin release patter

maximum tolerated dose

Full Information

NCT ID

NCT01116635

First Posted

May 3, 2010

Last Updated

March 14, 2014

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01116635

Brief Title

Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

Official Title

Phase I/II Study Examining Pharmacokinetics, Adverse Events, and Surgically Resected Histopathological Response Utilizing a Dose Escalation Model of Doxorubicin Loaded Drug Eluting Superabsorbent Polymer Microspheres in Surgically Resectable Hepatocellular Carcinoma in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

chemoembolization, drug eluting microsphere, hepato, embolotherapy, downstage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50mg dose loading per vial of doxorubicin

Arm Type

Experimental

Arm Title

75mg dose loading per vial of doxorubicin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

doxorubicin, superabsorbent polymer microspheres, embolotherapy

Other Intervention Name(s)

chemoembolization, drug eluting bead, drug eluting microsphere, superabsorbent microsphere, radioembolization, bland embolization

Intervention Description

varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere.

Primary Outcome Measure Information:

Title

Histopathological correlation with surgically resected tumor

Secondary Outcome Measure Information:

Title

Dose limiting toxicities

Title

serum doxorubicin release patter

Title

maximum tolerated dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Chung, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jo-Ann Ford, RN

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sharlene Gill, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Stephen Ho, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Owen, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Charles Scudamore, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ellen Wasan, PhD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Alan Weiss, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Eric Yoshida, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sigfried Erb, MD

Organizational Affiliation

University of British Columbia

Official's Role

Study Director

Facility Information:

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24982375

Citation

Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Res. 2014 Jul;34(7):3597-606.

Results Reference

derived

Learn more about this trial

Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

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