Adult Primary Hepatocellular CarcinomaEarly Phase 1NCT02072356
Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
A Early Phase 1 study testing yttrium Y 90 glass microspheres, laboratory biomarker analysis and TheraSphere in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
- What is being tested?
- yttrium Y 90 glass microspheres, laboratory biomarker analysis and TheraSphere
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2010to 15 Jun 2021
- Phase
- Early Phase 1
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Life expectancy >= 3 months
- > 4 weeks since prior radiation, surgery or chemotherapy
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
- Ineligible for surgical resection
Who cannot join
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
- Any contraindications to angiography and hepatic artery catheterization such as:
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated
- Bleeding diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization
Show all 14Show fewer
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- Evidence of pulmonary insufficiency
- Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
- Significant extrahepatic disease representing an imminent life-threatening outcome
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. 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 an effective treatment for liver cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
OUTLINE:
Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.
- Conditions
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
- Being tested
- yttrium Y 90 glass microspheres, laboratory biomarker analysis, TheraSphere
- Keywords
- Humanitarian Device, Carcinoma, Hepatocellular Carcinoma, TheraSphere®, HUD
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yttrium Y 90 glass microspheresRadiation
Also called TheraSphere
Given Interartrial
laboratory biomarker analysisOther
Also called Correlative studies, AFP
Alpha-fetoprotein assay
TheraSphereDrug
TheraSphere is delivered into the liver tumor through a catheter placed into the hepatic artery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (yttrium Y 90 glass microspheres) | Experimental | Patients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. Receives: Radiation: yttrium Y 90 glass microspheres; Other: laboratory biomarker analysis; Drug: TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Measured: Up to 2 years
Survival time
Measured: Up to 2 years
Adverse experiences
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start11 Oct 2010
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Primary Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rikabi, Ohio State University Comprehensive Cancer Center
- Investigators
- Rikabi Ali, M.D., Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072356
- Sponsor's protocol ID
- OSU-10036
- Other IDs
- NCI-2012-00877
- Status last verified
- Sep 2022
- First submitted
- 24 Feb 2014
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02072356
- Acronym / sponsor ID
- OSU-10036
- Conditions
- Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer
- Keywords
- Humanitarian Device, Carcinoma, Hepatocellular Carcinoma, TheraSphere®, HUD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 11 Oct 2010 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 26 Feb 2014 (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.
This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. 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 an effective treatment for liver cancer.
Detailed description
PRIMARY OBJECTIVES:
- Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
OUTLINE:
Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (yttrium Y 90 glass microspheres) | Experimental | Radiation: yttrium Y 90 glass microspheres, Other: laboratory biomarker analysis, Drug: TheraSpherePatients receive yttrium Y 90 glass microspheres IA on day 0. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
- Life expectancy >= 3 months
- > 4 weeks since prior radiation, surgery or chemotherapy
- Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Key exclusion criteria (14 listed)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (UNL)
- Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
- Any contraindications to angiography and hepatic artery catheterization such as:
- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
- Evidence of pulmonary insufficiency
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 |
|---|---|---|
| yttrium Y 90 glass microspheresAlso: TheraSphereGiven Interartrial | Radiation | Treatment (yttrium Y 90 glass microspheres) |
| laboratory biomarker analysisAlso: Correlative studies, AFPAlpha-fetoprotein assay | Other | Treatment (yttrium Y 90 glass microspheres) |
| TheraSphereTheraSphere is delivered into the liver tumor through a catheter placed into the hepatic artery. | Drug | Treatment (yttrium Y 90 glass microspheres) |
Primary outcome
Response to treatment
Time frame: Up to 2 years
Survival time
Time frame: Up to 2 years
Adverse experiences
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Adult Primary Hepatocellular Carcinoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Active, not recruitingPhase 1
Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
Adult Solid Neoplasm, Bladder Carcinoma
RecruitingPhase 1/2
First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours
Hepatocellular Carcinoma
RecruitingPhase 1
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations
Metastatic Hepatocellular Carcinoma, Solid Tumors
RecruitingPhase 1
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma
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.
Rikabi Ali, M.D. principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing yttrium Y 90 glass microspheres, laboratory biomarker analysis and TheraSphere in people with Adult Primary Hepatocellular Carcinoma and Advanced Adult Primary Liver Cancer, run by Ohio State University Comprehensive Cancer 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 30 Sep 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Response to treatment (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 30 Sep 2022.