Back to resultsTherasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer
Primary Purpose
Carcinoma, Hepatocellular, Neoplasm Metastasis
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
yttrium Y 90 microspheres (Therasphere®)
Sponsored by
About this trial
This is an expanded access trial for Carcinoma, Hepatocellular
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
- The cancer must be unresectable with limited established treatment options
- ECOG Performance Status Score 0-2
- Age 19 years or older
- Able to comprehend and provide written informed consent
Exclusion Criteria:
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count ≤ 1,500/ul
- Platelet count ≤ 75,000/ul
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin ≥ 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization:
- 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
- Substantial venous shunt away from the liver
- Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
- Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
- Significant extrahepatic disease representing an imminent life- threatening situation outcome
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Pregnant women may not participate
Sites / Locations
- Leo W Jenkins Cancer Center at East Carolina University School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00701168
First Posted
June 17, 2008
Last Updated
August 22, 2017
Sponsor
Leo W. Jenkins Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00701168
Brief Title
Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer
Official Title
A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leo W. Jenkins Cancer Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Neoplasm Metastasis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
yttrium Y 90 microspheres (Therasphere®)
Intervention Description
This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
The cancer must be unresectable with limited established treatment options
ECOG Performance Status Score 0-2
Age 19 years or older
Able to comprehend and provide written informed consent
Exclusion Criteria:
Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
Absolute granulocyte count ≤ 1,500/ul
Platelet count ≤ 75,000/ul
Serum creatinine > 2.0 mg/dl
Serum bilirubin ≥ 2.0 mg/dl
Any of the following contraindications to angiography and selective visceral catheterization:
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
Substantial venous shunt away from the liver
Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
Significant extrahepatic disease representing an imminent life- threatening situation outcome
Severe liver dysfunction or pulmonary insufficiency
Active uncontrolled infection
Significant underlying medical or psychiatric illness
Pregnant women may not participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Russo, MD
Organizational Affiliation
East Carolina University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leo W Jenkins Cancer Center at East Carolina University School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
12. IPD Sharing Statement
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Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer
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