Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00589030
First received: January 3, 2008
Last updated: May 6, 2013
Last verified: May 2013

January 3, 2008
May 6, 2013
April 2007
April 2013   (final data collection date for primary outcome measure)
  • Access to treatment [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
  • Patient experience associated with treatment [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: Yes ]
  • Liver database [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
  • Access to treatment [ Designated as safety issue: No ]
  • Patient experience associated with treatment [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Liver database [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00589030 on ClinicalTrials.gov Archive Site
Tumor response rate [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]
Tumor response rate [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.

PURPOSE: This phase II trial is studying the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

  • Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with primary cancer to the liver and who are not surgical resection candidates.
  • Evaluate patient experience and toxicities associated with TheraSphere® treatment.
  • Enter treatment experience into a liver database.

Secondary

  • Determine the tumor response rates in patients receiving this treatment.

OUTLINE: This is a humanitarian device exemption use study.

Patients receive yttrium Y 90 glass microspheres (TheraSphere®) via percutaneous hepatic arterial infusion. Patients may be retreated between 30-90 days after the initial infusion.

After completion of study therapy, patients are followed for 30 days and then annually thereafter for up to 2 years.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
  • Radiation: brachytherapy
    The target dose of TheraSphere® is 80-150Gy
  • Radiation: yttrium Y 90 glass microspheres
    The target dose of TheraSphere® is 80-150Gy
Experimental: Treatment (radiation therapy)
Patients receive yttrium Y 90 glass microspheres via hepatic arterial infusion. Beginning 4-12 weeks later, some patients may receive additional treatment courses.
Interventions:
  • Radiation: brachytherapy
  • Radiation: yttrium Y 90 glass microspheres
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
Not Provided
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of hepatocellular carcinoma
  • Surgical evaluation by a member of the Liver Tumor Program must conclude the patient is not a candidate for resection or ablation
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
  • Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Absolute granulocyte count =<1,500/ul
  • Platelet count =<75,000/ul
  • Serum creatinine >= 2.0 mg/dl
  • Serum bilirubin * >= 2.0 mg/dl for bilateral treatment or lobar treatment * > 3.0 mg/dl for single lesion which could be treated by segmental fusion
  • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
  • Bleeding, diathesis not correctable by usual forms of therapy
  • Severe peripheral vascular disease that would preclude catheterization
  • Portal hypertension with portal venous shunt away from the liver
  • Evidence of potential delivery greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments
  • Evidence of any detectable Tc-99m MMA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy)
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnant women may not participate
  • Children may not participate
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00589030
06057, P30CA033572, CHNMC-06057, CDR0000579146, NCI-2010-00429
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Yi-Jen Chen, MD, PhD City of Hope Medical Center
City of Hope Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP