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

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by:

Leo W. Jenkins Cancer Center

ClinicalTrials.gov Identifier:

NCT00701168

First received: June 17, 2008

Last updated: October 4, 2010

Last verified: October 2010

History of Changes

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 What is 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: Yttrium

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

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

More Information

Publications:

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Yamada R, Kishi K, Sato M, Sonomura T, Nishida N, Tanaka K, Shioyama Y, Terada M, Kimura M. Transcatheter arterial chemoembolization (TACE) in the treatment of unresectable liver cancer. World J Surg. 1995 Nov-Dec;19(6):795-800.

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[No authors listed] A comparison of lipiodol chemoembolization and conservative treatment for unresectable hepatocellular carcinoma. Groupe d'Etude et de Traitement du Carcinome Hépatocellulaire. N Engl J Med. 1995 May 11;332(19):1256-61.

Pelletier G, Roche A, Ink O, Anciaux ML, Derhy S, Rougier P, Lenoir C, Attali P, Etienne JP. A randomized trial of hepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma. J Hepatol. 1990 Sep;11(2):181-4.

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Responsible Party:	Suzanne Russo, MD, Principal Investigator, East Carolina University School of Medicine
ClinicalTrials.gov Identifier:	NCT00701168 History of Changes
Other Study ID Numbers:	LJCC 07-04
Study First Received:	June 17, 2008
Last Updated:	October 4, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Liver Neoplasms
Neoplasm Metastasis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Adenocarcinoma

ClinicalTrials.gov processed this record on May 16, 2013

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