TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, Irvine
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00906984
First received: December 27, 2007
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment will be examined. This study will provide supervised and limited access to TheraSphere treatment at University California Irvine Medical Center.

TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. This allows a large dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. The radiation from TheraSphere is contained within the body and becomes minimally active within 7 days after treatment due to physical decay. The glass beads remain in the body, but do not cause any health problems. TheraSphere has been approved for use in the treatment of liver cancer in the United States by the Food and Drug Administration on a limited basis.


Condition Intervention
Hepatocellular Carcinoma
Liver Cancer
Liver Neoplasm
Primary Liver Cancer
Device: TheraSphere

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • The protocol allows for prospective collection of data. There is no randomization to an alternative form of therapy. However, we measure tumor response after treatment based on CT scans and tumor markers. [ Time Frame: Every 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate for side effects [ Time Frame: Every 1-2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: May 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: TheraSphere® treatment

TheraSphere® treatment will be performed in the outpatient setting.

Within two weeks (14 days) of initial treatment, a catheter will be placed and liver angiography will be performed to confirm eligibility, followed by a Technetium-99 Macroaggregated Albumin (Tc-99m MAA) study. If either study indicates an uncorrectable risk of flow to the gastrointestinal organs or risk of shunting to the lungs, TheraSphere® treatment will not be administered. In this event, the patient will receive alternative treatment (chemoembolization) or no treatment, as previously defined in the treatment plan. If the patient remains eligible, TheraSphere® will be administered within two weeks.

All patients will be evaluated at 30 days post-treatment to assess clinical experience and adverse experiences. Subsequently, patient status will be followed via communication with the referring oncologist to determine disease status and survival. Survival surveillance will continue up to 24 months.

Device: TheraSphere
Given IV

Detailed Description:

This protocol provides TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. Patients with hepatocellular carcinoma will be evaluated for eligibility for this treatment with the following: physical examination, medical history, blood tests requiring approximately 2 tablespoons of blood, EKG, CT or MR of chest to examine lungs, CT or magnetic resonance (MR) of abdomen to evaluate liver, stomach and intestines, and bone scan to rule out spread of disease to bones. If eligible on initial screening, patients will proceed to a second stage of screening, including an hepatic angiogram to confirm treatment can be provided safely and to highlight the blood vessels supplying the liver, and a nuclear medicine study (Tc-99m MAA scan) to display the blood flow to the lungs, stomach and intestines.

When it is determined treatment can be delivered safely, patients will receive TheraSphere via the hepatic artery through blood vessels supplying the liver on an outpatient basis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of intrahepatic carcinoma. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as Alpha-fetoprotein assay (AFP) (clinical diagnosis).
  • The cancer must be unresectable.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
  • Age ≥ 18 years.
  • Able to comprehend and read the study information sheet in accordance with institutional and federal guidelines.

Exclusion Criteria:

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

    • Absolute granulocyte count ≤ 1,500/ul
    • Platelet count ≤ 75,000/μl
    • 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.
  • Portal hypertension with portal venous shunt away from the liver.
  • Evidence of potential delivery of greater than 16.5 millicurie (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 or pulmonary insufficiency.
  • Active uncontrolled infection.
  • Significant underlying medical or psychiatric illness.
  • Pregnant women may not participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906984

Contacts
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center (877) 827-8839 UCstudy@uci.edu

Locations
United States, California
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Principal Investigator: David K Imagawa, MD, PhD         
Sponsors and Collaborators
University of California, Irvine
BTG International Inc.
Investigators
Principal Investigator: David K Imagawa, MD, PhD University of California, Irvine
  More Information

Additional Information:
Publications:
Responsible Party: Chao Family Comprehensive Cancer Center, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00906984     History of Changes
Other Study ID Numbers: UCI 01-61, CA60396, 2002-2242
Study First Received: December 27, 2007
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Hepatocellular carcinoma
Liver cancer
Primary liver cancer
Unresectable liver cancer
Unresectable hepatocellular carcinoma
TheraSphere

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on July 22, 2014