Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

Expanded access is currently available for this treatment.

Verified by Leo W. Jenkins Cancer Center, June 2008

First Received: June 17, 2008 Last Updated: June 18, 2008 History of Changes

Sponsored by:	Leo W. Jenkins Cancer Center
Information provided by:	Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:	NCT00701168

Purpose

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.

Condition	Intervention
Carcinoma, Hepatocellular Neoplasm Metastasis	Device: yttrium Y 90 microspheres (Therasphere®)

Study Type:	Expanded Access
Official Title:	A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: TheraSphere

U.S. FDA Resources

Further study details as provided by Leo W. Jenkins Cancer Center:

Intervention Details:

This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
The cancer must be unresectable with limited established treatment options
ECOG Performance Status Score 0-2
Age 19 years or older
Able to comprehend and provide written informed consent

Exclusion Criteria:

Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
Absolute granulocyte count ≤ 1,500/ul
Platelet count ≤ 75,000/ul
Serum creatinine > 2.0 mg/dl
Serum bilirubin ≥ 2.0 mg/dl
Any of the following contraindications to angiography and selective visceral catheterization:
History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
Bleeding, diathesis, not correctable by usual forms of therapy
Severe peripheral vascular disease that would preclude catheterization
Substantial venous shunt away from the liver
Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
Significant extrahepatic disease representing an imminent life- threatening situation outcome
Severe liver dysfunction or pulmonary insufficiency
Active uncontrolled infection
Significant underlying medical or psychiatric illness
Pregnant women may not participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701168

Contacts

Contact: Suzanne Russo, MD	252-744-2900	russos@ecu.edu
Contact: Michelle Sagraves, RN	252-744-3617	sagravesm@ecu.edu

Locations

United States, North Carolina
Leo W Jenkins Cancer Center at East Carolina University School of Medicine
Greenville, North Carolina, United States, 27834

Sponsors and Collaborators

Leo W. Jenkins Cancer Center

Investigators

Principal Investigator:

Suzanne Russo, MD

East Carolina University School of Medicine

Responsible Party:	East Carolina University School of Medicine ( Suzanne Russo, MD, Principal Investigator )
Study ID Numbers:	LJCC 07-04
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701168 History of Changes
Health Authority:	United States: Institutional Review Board