Back to resultsRadiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Primary Purpose
Liver Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
yttrium Y 90 glass microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Confirmed diagnosis of hepatocellular carcinoma (HCC) Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level No significant extrahepatic disease that may represent an imminent life-threatening outcome No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract PATIENT CHARACTERISTICS: ECOG performance status 0-2 No hepatic dysfunction Bilirubin ≤ 2.0 mg/dL No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization No pulmonary insufficiency No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow No contraindications to angiography No contraindications to selective visceral catheterization No other condition or cormorbidity that would preclude study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 30 days after study PRIOR CONCURRENT THERAPY: At least 1 month since prior chemotherapy, radiotherapy, or surgery No other concurrent investigational agents or anticancer therapy for HCC
Sites / Locations
- UPMC Liver Cancer Center
Outcomes
Primary Outcome Measures
Response to treatment
Survival time from treatment
Adverse experiences
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00039078
Brief Title
Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Official Title
The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Record created in error - not a research study
Study Start Date
August 2000 (undefined)
Primary Completion Date
August 2000 (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Allan Tsung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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 hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
Determine the toxic effects and adverse experiences associated with this therapy in these patients.
Determine the survival time of patients treated with this therapy.
Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
Assess the quality of life of patients treated with this therapy.
OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.
Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 glass microspheres
Primary Outcome Measure Information:
Title
Response to treatment
Title
Survival time from treatment
Title
Adverse experiences
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Confirmed diagnosis of hepatocellular carcinoma (HCC)
Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level
No significant extrahepatic disease that may represent an imminent life-threatening outcome
No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
No hepatic dysfunction
Bilirubin ≤ 2.0 mg/dL
No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization
No pulmonary insufficiency
No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
No contraindications to angiography
No contraindications to selective visceral catheterization
No other condition or cormorbidity that would preclude study treatment
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 30 days after study
PRIOR CONCURRENT THERAPY:
At least 1 month since prior chemotherapy, radiotherapy, or surgery
No other concurrent investigational agents or anticancer therapy for HCC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. Clark Gamblin, MD
Organizational Affiliation
UPMC Cancer Center at UPMC Presbyterian
Official's Role
Study Chair
Facility Information:
Facility Name
UPMC Liver Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15713920
Citation
Goin JE, Salem R, Carr BI, Dancey JE, Soulen MC, Geschwind JF, Goin K, Van Buskirk M, Thurston K. Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: a risk-stratification analysis. J Vasc Interv Radiol. 2005 Feb;16(2 Pt 1):195-203. doi: 10.1097/01.RVI.0000142602.79459.90.
Results Reference
background
PubMed Identifier
15508085
Citation
Geschwind JF, Salem R, Carr BI, Soulen MC, Thurston KG, Goin KA, Van Buskirk M, Roberts CA, Goin JE. Yttrium-90 microspheres for the treatment of hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S194-205. doi: 10.1053/j.gastro.2004.09.034.
Results Reference
background
PubMed Identifier
12354840
Citation
Salem R, Thurston KG, Carr BI, Goin JE, Geschwind JF. Yttrium-90 microspheres: radiation therapy for unresectable liver cancer. J Vasc Interv Radiol. 2002 Sep;13(9 Pt 2):S223-9. doi: 10.1016/s1051-0443(07)61790-4.
Results Reference
background
PubMed Identifier
14762849
Citation
Carr BI. Hepatic arterial 90Yttrium glass microspheres (Therasphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients. Liver Transpl. 2004 Feb;10(2 Suppl 1):S107-10. doi: 10.1002/lt.20036.
Results Reference
result
Citation
Carr BI, Sheetz M, Brown M, et al.: Hepatic arterial 90yttrium-labeled glass microspheres (Therasphere) as treatment for unresectable HCC in forty three patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-553, 2002.
Results Reference
result
Citation
Carr BI, Brown M, France M, et al.: 90 yttrium labeled glass microspheres in the treatment of hepatocellular carcinoma: initial US experience. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2346, 2001.
Results Reference
result
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Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
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