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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular, Liver Neoplasms

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

James P Flynn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwestern Regional Medical Center

Authority:

United States: Institutional Review Board

Study ID:

CTCT 06-11

NCT ID:

NCT00493883

Start Date:

December 2006

Completion Date:

December 2011

Related Keywords:

  • Carcinoma, Hepatocellular
  • Liver Neoplasms
  • Therasphere
  • Yttrium
  • liver
  • cancer
  • radiation
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
Cancer Treatment Centers of America at Southwestern Regional Medical Center Tulsa, Oklahoma  74133-4564