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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT00493883
First received: June 26, 2007
Last updated: December 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Carcinoma, Hepatocellular
Liver Neoplasms
 Device: yttrium Y 90 microspheres (TheraSphere®)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southwestern Regional Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Survival time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: December 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493883

Locations
United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133
Sponsors and Collaborators
Southwestern Regional Medical Center
Investigators
Principal Investigator: James P Flynn, MD Southwestern Regional Medical Center
  More Information

Additional Information:
Click here for more information about this study: Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Southwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT00493883     History of Changes
Other Study ID Numbers: CTCT 06-11
Study First Received: June 26, 2007
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southwestern Regional Medical Center:
Therasphere
Yttrium
liver
cancer
radiation

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on June 18, 2013