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Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

Treatment of Patients With Hepatocellular Carcinoma Using Drug-Eluting Bead Embolization


OBJECTIVES:

- Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads
mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular
carcinoma.

OUTLINE: This is a pilot study.

Patients undergo catheterization of the hepatic artery followed by chemoembolization
comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the
target hepatic artery. Patients may receive up to 3 chemoembolization treatments.

After completion of study treatment, patients are followed at 1 month, every 2 months for 1
year, and then every 3 months during year 2.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for
the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging
classification

- No advanced disease, as defined by any of the following:

- Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the
following:

- Vascular invasion, including segmental portal obstruction

- Extrahepatic spread

- Cancer-related symptoms (PST of 1-2)

- BCLC class D disease, as defined by the following:

- Okuda stage III disease

- WHO performance status 3 or 4

- Diffuse HCC, defined as massive ill-defined tumor involvement

- Child-Pugh Class C

- Not eligible for radical therapies (e.g., resection, liver transplantation, or
percutaneous therapies)

- No significant liver decompensation

- Preserved liver function (Child-Pugh class A-B)

- No ascites (trace ascites allowed)

- No other active primary tumor

- Arteries supplying the lesion must be large enough to accept GelSpheres™ beads

PATIENT CHARACTERISTICS:

- Bilirubin ≤ 3 mg/dL

- Albumin > 2.0 g/dL

- AST and ALT ≤ 5 times the upper limit of normal (ULN)

- Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)

- No active gastrointestinal bleeding

- No encephalopathy

- No contraindication to hepatic embolization procedures, as indicated by any of the
following:

- Porto-systemic shunt

- Hepatofugal blood flow

- Platelet count < 50,000/mm^3

- INR ≥ 1.8

- PTT ≥ 39 seconds

- Renal failure

- Severe atheromatosis

- No contraindication to doxorubicin hydrochloride administration, as indicated by any
of the following:

- Bilirubin > 5 mg/dL

- WBC < 1,500/mm^3

- Ejection fraction < 50% by isotopic ventriculography or echocardiography

- Not pregnant

- No known allergy to contrast media

- No intolerance to occlusion procedures

- No vascular anatomy or bleeding that would preclude catheter placement or emboli
injection, as indicated by any of the following:

- Active or risk of hemorrhage

- Patent extra-to-intracranial anastomoses or shunts

- End arteries leading directly to the cranial nerves

- Feeding arteries smaller than distal branches from which they emerge

- Collateral vessel pathways that would potentially endanger normal territories
during embolization

PRIOR CONCURRENT THERAPY:

- No prior anticancer therapy for HCC

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety

Principal Investigator

Jeffrey F. Geschwind, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000456493

NCT ID:

NCT00293397

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410