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Hepatocellular CarcinomaPhase 2NCT00539643

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

A Phase 2 study testing Bead Block microspheres and Bead + Dox Arm in people with Hepatocellular Carcinoma and Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, Liver Cancer, Hepatoma
What is being tested?
Bead Block microspheres and Bead + Dox Arm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteUnited States
Study dates
Nov 2007to 17 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Bead Block microspheres, Bead + Dox Arm
Keywords
Liver Cancer, Hepatoma, 07-099
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bead Block microspheresDevice

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

  • Bead + Dox ArmOther

    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.

Study groups in NCT00539643
Study groupRoleWhat they receive
Bead ArmActive comparatorHepatic arterial embolization with Bead Block microspheres, beginning with 100 - 300 micron beads, and using larger particles if necessary until stasis is evident.
Receives: Device: Bead Block microspheres
Bead + Dox ArmActive comparatorHepatic 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.
Receives: Other: Bead + Dox Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 to 3 weeks

Secondary outcomes (3)

  1. Number of Participants Evaluated for Toxicity

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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. Overall Survival

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completion17 Jun 2022
  4. Study completion17 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00539643
Sponsor's protocol ID
07-099
Status last verified
Jun 2022
First submitted
3 Oct 2007
Last updated
18 Aug 2023

Publications

  • 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.

    PubMed 26834067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bead Block microspheres and Bead + Dox Arm in people with Hepatocellular Carcinoma and Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to Treatment by RECIST Criteria (time frame: 2 to 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00539643, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.

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