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Carcinoma, HepatocellularPhase 1/2NCT00493883

Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

A Phase 1/2 study testing yttrium Y 90 microspheres (TheraSphere®) in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by Southwestern Regional Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular, Liver Neoplasms
What is being tested?
yttrium Y 90 microspheres (TheraSphere®)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited States
Study dates
Dec 2006to Dec 2011
Phase
Phase 1/2
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

  • Age >= 18.
  • Cancer visible in liver on CT,MR,US or PET scan.
  • Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.
  • Life expectancy greater than 2 months
  • Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)
  • Patients have tried and/or are aware of all FDA approved therapies for their condition.

Who cannot join

  • Vascular shunt that cannot be corrected.
  • Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.
  • Pregnancy
  • Hematologic primary such as lymphoma, leukemia, myeloma.
  • Body weight 300 lbs. and above
  • Evidence of portal hypertension, splenomegaly or ascites.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer Treatment Centers of America at Southwestern Regional Medical Center

    Tulsa, Oklahoma, 74133

Other trials in United States

About this study

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.

The study has the following objectives:

  • Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver.
  • Evaluate patient experience and toxicities associated with TheraSphere treatment
  • Evaluate predisposing factors that may influence results and toxicity
Read the detailed description

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

  1. Range of patients who can be offered TheraSphere®
  2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity
  3. Survival time
  4. Determine response in relation to histology and other parameters
  5. Ability to tolerate repeat treatments
  6. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.
Being tested
yttrium Y 90 microspheres (TheraSphere®)
Keywords
Therasphere, Yttrium, liver, cancer, radiation
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • yttrium Y 90 microspheres (TheraSphere®)Device

    Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver

Study groups in NCT00493883
Study groupRoleWhat they receive
TheraSphereOtherY-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver --------------------------------------------------------------------------------
Receives: Device: yttrium Y 90 microspheres (TheraSphere®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity

    Measured: 2 to 3 months after treatment(s) up to 2 years

  2. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

    Measured: 2 years

  3. Survival time

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493883
Sponsor's protocol ID
CTCT 06-11
Status last verified
May 2015
First submitted
26 Jun 2007
Last updated
13 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Campbell AM, Bailey IH, Burton MA. Tumour dosimetry in human liver following hepatic yttrium-90 microsphere therapy. Phys Med Biol. 2001 Feb;46(2):487-98. doi: 10.1088/0031-9155/46/2/315.

    PubMed 11229728

  • Herba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Semin Oncol. 2002 Apr;29(2):152-9. doi: 10.1053/sonc.2002.31672.

    PubMed 11951213

  • Wong CY, Salem R, Raman S, Gates VL, Dworkin HJ. Evaluating 90Y-glass microsphere treatment response of unresectable colorectal liver metastases by [18F]FDG PET: a comparison with CT or MRI. Eur J Nucl Med Mol Imaging. 2002 Jun;29(6):815-20. doi: 10.1007/s00259-002-0787-4. Epub 2002 Mar 29.

    PubMed 12029557

  • 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.

    PubMed 15713920

  • Murthy R, Xiong H, Nunez R, Cohen AC, Barron B, Szklaruk J, Madoff DC, Gupta S, Wallace MJ, Ahrar K, Hicks ME. Yttrium 90 resin microspheres for the treatment of unresectable colorectal hepatic metastases after failure of multiple chemotherapy regimens: preliminary results. J Vasc Interv Radiol. 2005 Jul;16(7):937-45. doi: 10.1097/01.RVI.0000161142.12822.66.

    PubMed 16002501

  • Wong CY, Qing F, Savin M, Campbell J, Gates VL, Sherpa KM, Lewandowski RJ, Nagle C, Salem R. Reduction of metastatic load to liver after intraarterial hepatic yttrium-90 radioembolization as evaluated by [18F]fluorodeoxyglucose positron emission tomographic imaging. J Vasc Interv Radiol. 2005 Aug;16(8):1101-6. doi: 10.1097/01.RVI.0000168104.32849.07.

    PubMed 16105922

  • Salem R, Lewandowski RJ, Atassi B, Gordon SC, Gates VL, Barakat O, Sergie Z, Wong CY, Thurston KG. Treatment of unresectable hepatocellular carcinoma with use of 90Y microspheres (TheraSphere): safety, tumor response, and survival. J Vasc Interv Radiol. 2005 Dec;16(12):1627-39. doi: 10.1097/01.RVI.0000184594.01661.81.

    PubMed 16371529

  • Lewandowski RJ, Thurston KG, Goin JE, Wong CY, Gates VL, Van Buskirk M, Geschwind JF, Salem R. 90Y microsphere (TheraSphere) treatment for unresectable colorectal cancer metastases of the liver: response to treatment at targeted doses of 135-150 Gy as measured by [18F]fluorodeoxyglucose positron emission tomography and computed tomographic imaging. J Vasc Interv Radiol. 2005 Dec;16(12):1641-51. doi: 10.1097/01.RVI.0000179815.44868.66.

    PubMed 16371530

  • Wong CY, Savin M, Sherpa KM, Qing F, Campbell J, Gates VL, Lewandowski RJ, Cheng V, Thie J, Fink-Bennett D, Nagle C, Salem R. Regional yttrium-90 microsphere treatment of surgically unresectable and chemotherapy-refractory metastatic liver carcinoma. Cancer Biother Radiopharm. 2006 Aug;21(4):305-13. doi: 10.1089/cbr.2006.21.305.

    PubMed 16999596

  • Salem R, Thurston KG. Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol. 2006 Oct;17(10):1571-93. doi: 10.1097/01.RVI.0000236744.34720.73.

    PubMed 17056999

  • Sato K, Lewandowski RJ, Bui JT, Omary R, Hunter RD, Kulik L, Mulcahy M, Liu D, Chrisman H, Resnick S, Nemcek AA Jr, Vogelzang R, Salem R. Treatment of unresectable primary and metastatic liver cancer with yttrium-90 microspheres (TheraSphere): assessment of hepatic arterial embolization. Cardiovasc Intervent Radiol. 2006 Jul-Aug;29(4):522-9. doi: 10.1007/s00270-005-0171-4.

    PubMed 16729228

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing yttrium Y 90 microspheres (TheraSphere®) in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by Southwestern Regional 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 6 inclusion and 6 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 13 May 2015. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity (time frame: 2 to 3 months after treatment(s) 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?

On the ClinicalTrials.gov record for NCT00493883, which also lists 11 linked publications.

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 13 May 2015.

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Clinical Trial NCT00493883 | AzTrials