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Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer, Hepatoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bead Block microspheres

Bead + Dox Arm

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Liver Cancer, Hepatoma, 07-099

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis; who is not a surgical resection candidate, or refuses surgery
Patient must be 18 years of age or older
Patient must be Okuda stage I or II
Patient must have an ECOG performance status of 0 or 1
No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all toxicities, if any, resolved to grade < than or = to 1
Patient must have the following laboratory values confirmed within 14 days of registration:
Creatinine ≤ than or = to 2.0 the institution ULN
Platelets ≥ than or = to 50,000/mm3
INR ≤ than or = to 2.0 for patients who are not on Coumadin
aPTT < or = to twice control
Bilirubin < 3 mg/dl
WBC > 3000 cells/mm3
ANC > 1500 cells/mm3
Negative serum pregnancy test (Female of childbearing potential only)

Exclusion Criteria:

Patient has another primary tumor, with the exception of conventional basal cell CA, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease
Women who are pregnant or lactating
Patient previously treated with doxorubicin
Contraindication to angiography/embolization including: patients who cannot receive contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on judgment of the investigator
Patient has already undergone hepatic arterial embolization for the hepatocellular cancer for which they are currently being evaluated
Patient has received prior radiotherapy for the hepatocellular cancer for which they are currently being evaluated
Patient has had previous local-regional treatment of the current target tumor volume
Patient who cannot have CT scan
Patient at very high risk for post-embolization hepatic failure: 1. Child's C cirrhosis, 2. > 75% liver replaced by tumor
Cardiac exclusion for: 1. Myocardial infarction within 90 days of study, 2. uncontrolled arrhythmia, 3. LVEF < 50% for patients randomized to receive LC Bead
Patients with tumors exhibiting characteristics considered contra-indications to particle embolization, including: 1. collateral vessel pathways potentially endangering normal territories during embolization, 2. arteries supplying tumor not large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic venous shunts, 4. Presence of arterial to pulmonary vascular shunts

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Bead Arm

Bead + Dox Arm

Arm Description

Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.

Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Outcomes

Primary Outcome Measures

Response to Treatment by RECIST Criteria

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Number of Participants Evaluated for Toxicity

Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 3.0.

Progression Free Survival

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Overall Survival

Full Information

NCT ID

NCT00539643

First Posted

October 3, 2007

Last Updated

August 14, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT00539643

Brief Title

Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

Official Title

A Randomized Single Blind Controlled Trial of Beads vs. Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma (HCC)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 2007 (Actual)

Primary Completion Date

June 17, 2022 (Actual)

Study Completion Date

June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Columbia University

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.

Detailed Description

Biocompatibles LC Bead (also known as DC Bead in Asia & Europe) microspheres are preformed soft, deformable microspheres that may be loaded with doxorubicin and used to occlude blood flow to a cancerous tumour. LC Bead microspheres consist of a macromere derived from PVA. The fully polymerized microsphere is approximately 90% water and is compressible to approximately 30% by diameter. The microspheres can be delivered through conventional catheters (4-5Fr) or micro-catheters in the 2-3Fr range. These microspheres, like all agents used for arterial embolization, are mixed with radiographic contrast prior to administration in order to allow for fluoroscopic control of the embolization procedure.

6. Conditions and Keywords

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

Hepatocellular Carcinoma, Liver Cancer, Hepatoma

Keywords

Liver Cancer, Hepatoma, 07-099

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bead Arm

Arm Type

Active Comparator

Arm Description

Hepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.

Arm Title

Bead + Dox Arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Bead Block microspheres

Intervention Description

Bead Block (Beads) microsphere, 100-300 micron with additional larger size beads as necessary to achieve stasis

Intervention Type

Other

Intervention Name(s)

Bead + Dox Arm

Intervention Description

Bead + Dox Arm: Hepatic arterial embolization with 100-300 micron drug eluting microspheres (LC Bead) loaded with 150 mg Doxorubicin, followed by embolization with Bead Block microspheres (100-300 micron and larger size beads as necessary) until stasis is evident.

Primary Outcome Measure Information:

Title

Response to Treatment by RECIST Criteria

Description

Time Frame

2 to 3 weeks

Secondary Outcome Measure Information:

Title

Number of Participants Evaluated for Toxicity

Description

Toxicity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 3.0.

Time Frame

1 year

Title

Progression Free Survival

Description

Time Frame

1 year

Title

Overall Survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with a confirmed diagnosis of HCC according to EASL criteria for diagnosis; who is not a surgical resection candidate, or refuses surgery Patient must be 18 years of age or older Patient must be Okuda stage I or II Patient must have an ECOG performance status of 0 or 1 No prior chemotherapy or biotherapy within 4 weeks of scheduled embolization, with all toxicities, if any, resolved to grade < than or = to 1 Patient must have the following laboratory values confirmed within 14 days of registration: Creatinine ≤ than or = to 2.0 the institution ULN Platelets ≥ than or = to 50,000/mm3 INR ≤ than or = to 2.0 for patients who are not on Coumadin aPTT < or = to twice control Bilirubin < 3 mg/dl WBC > 3000 cells/mm3 ANC > 1500 cells/mm3 Negative serum pregnancy test (Female of childbearing potential only) Exclusion Criteria: Patient has another primary tumor, with the exception of conventional basal cell CA, superficial bladder cancer, melanoma in situ, or treated prostate cancer currently without biochemical or radiographic evidence of active disease Women who are pregnant or lactating Patient previously treated with doxorubicin Contraindication to angiography/embolization including: patients who cannot receive contrast 1.Severe allergic reaction to contrast despite pre-medication, 2. poor renal function; 3.Lack of arterial access (eg femoral artery occlusion); 4. other, based on judgment of the investigator Patient has already undergone hepatic arterial embolization for the hepatocellular cancer for which they are currently being evaluated Patient has received prior radiotherapy for the hepatocellular cancer for which they are currently being evaluated Patient has had previous local-regional treatment of the current target tumor volume Patient who cannot have CT scan Patient at very high risk for post-embolization hepatic failure: 1. Child's C cirrhosis, 2. > 75% liver replaced by tumor Cardiac exclusion for: 1. Myocardial infarction within 90 days of study, 2. uncontrolled arrhythmia, 3. LVEF < 50% for patients randomized to receive LC Bead Patients with tumors exhibiting characteristics considered contra-indications to particle embolization, including: 1. collateral vessel pathways potentially endangering normal territories during embolization, 2. arteries supplying tumor not large enough to accept LC Bead or Bead Block, 3. Presence of arterial to systemic venous shunts, 4. Presence of arterial to pulmonary vascular shunts

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen T Brown, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26834067

Citation

Brown KT, Do RK, Gonen M, Covey AM, Getrajdman GI, Sofocleous CT, Jarnagin WR, D'Angelica MI, Allen PJ, Erinjeri JP, Brody LA, O'Neill GP, Johnson KN, Garcia AR, Beattie C, Zhao B, Solomon SB, Schwartz LH, DeMatteo R, Abou-Alfa GK. Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone. J Clin Oncol. 2016 Jun 10;34(17):2046-53. doi: 10.1200/JCO.2015.64.0821. Epub 2016 Feb 1.

Results Reference

derived

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

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Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma

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