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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

June 26, 2007
December 10, 2012
December 2006
December 2011   (final data collection date for 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 ] [ 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 ]
  • 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 ]
  • Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths. [ Time Frame: 2 years ]
  • Survival time [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00493883 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

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

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Hepatocellular
  • Liver Neoplasms
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
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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Intervention: Device: yttrium Y 90 microspheres (TheraSphere®)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00493883
CTCT 06-11
No
Southwestern Regional Medical Center
Southwestern Regional Medical Center
Not Provided
Principal Investigator: James P Flynn, MD Southwestern Regional Medical Center
Southwestern Regional Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP