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
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Radiation: brachytherapy
Radiation: yttrium Y 90 glass microspheres
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Tumor response rate [ Time Frame: 24 months after last treatment ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: April 2007
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Radiation: brachytherapy
The target dose of TheraSphere® is 80-150Gy
Radiation: yttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150Gy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589030

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Yi-Jen Chen, MD, PhD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00589030     History of Changes
Other Study ID Numbers: 06057, P30CA033572, CHNMC-06057, CDR0000579146, NCI-2010-00429
Study First Received: January 3, 2008
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014