A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere® - Full Text View

Sponsored by:	St. Joseph Hospital of Orange
Information provided by:	St. Joseph Hospital of Orange
ClinicalTrials.gov Identifier:	NCT00877136

Purpose

This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:

Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
Evaluate patient experience and toxicities associated with TheraSphere® treatment.
Measure tumor response rates

Condition	Intervention
Liver Tumors Hepatocellular Carcinoma Hepatoma Neoplasms	Device: TheraSphere®

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: TheraSphere

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

Further study details as provided by St. Joseph Hospital of Orange:

Primary Outcome Measures:

Evaluate patient quality of life and toxicities associated with TheraSphere® treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tumor response to treatment with TheraSphere® [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.

Detailed Description:

The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas

Criteria

Inclusion Criteria:

Confirmed diagnosis of hepatocellular carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass with known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP (clinical diagnosis)
Surgical evaluation must conclude the patient is not a candidate for resection or ablation.
ECOG Performance Status Score 0 - 2.
Age 18 years or older.
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

Absolute granulocyte count less than or equal to 1,500/ul
Uncorrected Platelet count less than or equal to 75,000/ul
Serum creatinine greater than or equal to 3.0 mg/dl
Serum bilirubin greater than or equal to 2.0 mg/dl
Any of the following contraindications to angiography and selective visceral catheterization, 1.)History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, 2.) Bleeding diathesis, not correctable by usual forms of therapy, and/or 3.) Severe peripheral vascular disease that would preclude catheterization.
Portal hypertension with portal venous shunt away from the liver.
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: 1) first TheraSphere® administration; or 2) cumulative delivery of radiation to the lungs > 30 Gy over multiple treatments.
Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
Significant extrahepatic disease representing an imminent life-threatening outcome.
Severe liver dysfunction (Childs' Classification C) or pulmonary insufficiency (requiring continuous oxygen therapy).
Active uncontrolled infection
Significant underlying medical or psychiatric illness.
Pregnant women may not participate.
Children may not participate due to lack of clinical experience.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877136

Contacts

Contact: Jessica Silvester	714-734-6220
Contact: Maria Gonzalez	714-734-6220

Locations

United States, California
The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange	Recruiting
Orange, California, United States, 92868
Contact: Jessica Silvester 714-734-6220
Contact: Maria Gonzalez 714-734-6220
Principal Investigator: Lawrence Wagman, M.D., F.A.C.S.
Sub-Investigator: Robert Ash, MD
Sub-Investigator: Afshin Forouzannia, MD
Sub-Investigator: Judith Harrison-Monge, MD
Sub-Investigator: Timothy Byun, MD
Sub-Investigator: Hisham El-Bayar, MD
Sub-Investigator: Kurt Openshaw, MD
Sub-Investigator: Mahmood Razavi, MD

Sponsors and Collaborators

St. Joseph Hospital of Orange

Investigators

Principal Investigator:

Lawrence Wagman, M.D., F.A.C.S.

St. Joseph Hospital of Orange

More Information

No publications provided

Responsible Party:	St. Joseph Hospital of Orange ( Lawrence Wagman, MD - Executive Medical Director, The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange )
Study ID Numbers:	08-029 TheraSphere®
Study First Received:	April 3, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00877136 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Joseph Hospital of Orange:

Liver tumors
Liver cancer
Adult primary hepatocellular carcinoma

HCC
Hepatoma
Neoplasms

Study placed in the following topic categories:

Liver Neoplasms
Methamphetamine
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Amphetamine
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009