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

May 12, 2015 updated by: Southwestern Regional Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Cancer Treatment Centers of America at Southwestern Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age >= 18.
  2. Cancer visible in liver on CT,MR,US or PET scan.
  3. 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.
  4. Life expectancy greater than 2 months
  5. 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.)
  6. Patients have tried and/or are aware of all FDA approved therapies for their condition.

Exclusion Criteria:

  1. Vascular shunt that cannot be corrected.
  2. 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.
  3. Pregnancy
  4. Hematologic primary such as lymphoma, leukemia, myeloma.
  5. Body weight 300 lbs. and above
  6. Evidence of portal hypertension, splenomegaly or ascites.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TheraSphere

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

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Device: yttrium Y 90 microspheres (TheraSphere®)
Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival time
Time Frame: 2 years
2 years
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
2 to 3 months after treatment(s) up to 2 years
Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwestern Regional Medical Center

Investigators

  • Principal Investigator: James P Flynn, MD, Southwestern Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (Estimate)

June 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCT 06-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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