Liver CancerNCT00589030
Yttrium Y 90 Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
A study testing brachytherapy and yttrium Y 90 glass microspheres in people with Liver Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- brachytherapy and yttrium Y 90 glass microspheres
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2014
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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:
- first TheraSphere administration; or
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: 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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- brachytherapy, yttrium Y 90 glass microspheres
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
The target dose of TheraSphere® is 80-150Gy
yttrium Y 90 glass microspheresRadiation
The target dose of TheraSphere® is 80-150Gy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Jen Chen, MD, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589030
- Sponsor's protocol ID
- 06057
- Other IDs
- CHNMC-06057, CDR0000579146, NCI-2010-00429
- Status last verified
- Feb 2017
- First submitted
- 3 Jan 2008
- Last updated
- 15 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere (Yttrium-90 Glass Microspheres): A HDE Treatment Use Protocol
- ClinicalTrials.gov ID
- NCT00589030
- Acronym / sponsor ID
- 06057
- Conditions
- Liver Cancer
- Keywords
- adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: To provide expanded access and study the side effects of yttrium Y 90 glass microspheres in treating patients with liver cancer that cannot be removed by surgery.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- Absolute granulocyte count =<1,500/ul
- Platelet count =<75,000/ul
- Serum creatinine >= 2.0 mg/dl
- Serum bilirubin
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brachytherapyThe target dose of TheraSphere® is 80-150Gy | Radiation | – |
| yttrium Y 90 glass microspheresThe target dose of TheraSphere® is 80-150Gy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Jen Chen, MD, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brachytherapy and yttrium Y 90 glass microspheres in people with Liver Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.