Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
This study is ongoing, but not recruiting participants.
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00589030
First received: January 3, 2008
Last updated: September 7, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | March 2019 (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: | September 7, 2012 |
| 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 Amphetamine Methamphetamine Central Nervous System Stimulants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on October 17, 2012
