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Hepatocellular CarcinomaPhase 2DEBDOXNCT02007954

Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma

A Phase 2 study testing DEBDOX in people with Hepatocellular Carcinoma, run by Yale University 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 determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
DEBDOX
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Feb 2014to 18 Nov 2016
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

  • The patient has preserved liver function (Child-Pugh A-B class) without significant liver decompensation.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
  • The patient is age 18 years or older.
  • The patient has a life expectancy of > 12 weeks.
  • The patient has measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
  • The patient has adequate hematologic function as defined by the following criteria:
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  • An absolute neutrophil count (ANC) ≥ 1500/micro L,
  • Hemoglobin ≥ 9.5 g/dL, and a
  • Platelet count ≥ 50,000/micro L.
  • The patient has adequate hepatic function, as defined by the following criteria:
  • Total bilirubin </= 3.0 mg/dL
  • Aspartate transaminase (AST) and alanine transaminase (ALT) </= 8 x the upper limit of normal (ULN).
  • The patient has adequate renal function, as defined by the following criteria:
  • Serum creatinine </= 2.0 x the institutional ULN
  • The patient has a baseline international normalized ratio (INR) < 1.5.
  • The patient, if a woman of childbearing potential, has a negative pregnancy test.
  • The patient is able to give written informed consent.
  • The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans.
  • Patients with early stage HCC may be included in the protocol to receive DEBDOX-M1 prior to resection

Who cannot join

  • The patient has a history of another primary cancer (ie, a primary cancer not associated with the patient's current liver tumor), with the exception of (a) curatively resected nonmelanomatous skin cancer; (b) curatively treated cervical carcinoma in situ; or (c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to enrollment (date of informed consent).
  • The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, targeted therapy, or an investigational agent.
  • The patient has extrahepatic, metastatic, symptomatic HCC. Enlarged reactive lymph nodes, or indeterminate lesions, such as lung nodules are acceptable.
  • The patient's tumor has replaced >70% of the liver volume.
  • The patient has clinically significant ascites. Trace ascites on imaging is acceptable.
  • Marco-shunting noted on the hepatic angiogram.
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  • The patient has untreatable bleeding diathesis.
  • The patient has complete main portal vein thrombosis with reversal of flow.
  • The patient has a left ventricle ejection fraction of less than 45%.
  • The patient has evidence of clinically significant peripheral vascular disease.
  • The patient has clinically significant or symptomatic extrahepatic disease, for example, an uncontrolled inter-current illness including, but not limited to:
  • Ongoing or active infection requiring parenteral antibiotics
  • Symptomatic congestive heart failure (class II to IV of the New York Heart Association classification for heart disease)
  • Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
  • Uncontrolled hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg, found on 2 consecutive measurements separated by a 1-week period despite adequate medical support)
  • Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [NCI-CTCAE Grade 3] or asymptomatic sustained ventricular tachycardia)
  • Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
  • There is evidence of substance abuse or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
  • The patient is pregnant or breast-feeding.
  • The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
  • The patient has extra-hepatic, metastatic, and symptomatic HCC.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma (DEBDOX)

The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE) DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.

Being tested
DEBDOX
Keywords
HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • DEBDOXDevice

    DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.

Study groups in NCT02007954
Study groupRoleWhat they receive
DEBDOXExperimentalNot described
Receives: Device: DEBDOX

What is being measured

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

  1. Success of DEBDOX-M1 Procedure as a Measure of Feasibility

    Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.

    Measured: 6 months

  2. Collection of Adverse Events Related to Study Device as a Measure of Safety

    For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE.

    Measured: 1 month

Secondary outcomes (5)

  1. Efficacy - Tumor Response by EASL

    Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments.

    Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference.

    Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1.

    Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1.

    Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1.

    Measured: 1 month

  2. Efficacy - Tumor Response by qEASL

    Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments.

    Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.

    Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions.

    Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease.

    Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions.

    Measured: 1 month

  3. Efficacy - Tumor Response by mRECIST

    Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments.

    Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD.

    Measured: 1 month

  4. Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions

    The number of patients who underwent a liver transplantation following treatment on this protocol.

    Measured: 6 months

  5. AFP Tumor Marker Pre- and Post-treatment

    The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure.

    Measured: 1 month

Timeline

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

  1. First posted11 Dec 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completion11 Aug 2015
  4. Study completion18 Nov 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007954
Sponsor's protocol ID
J1306
Other IDs
NA_00077927
Acronym
DEBDOX
Status last verified
Jul 2014
First submitted
21 Nov 2013
Last updated
11 Aug 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DEBDOX in people with Hepatocellular Carcinoma, run by Yale University 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 19 inclusion and 21 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 11 Aug 2017. 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 11 Aug 2017). 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?

Success of DEBDOX-M1 Procedure as a Measure of Feasibility (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02007954.

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 11 Aug 2017.

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