TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Recruitment status was Recruiting
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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 Yttrium-90 microspheres |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TheraSphere Yttrium-90 Glass: Humanitarian Device Exemption Use Protocol for TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma |
- 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 ]
- Evaluate for side effects [ Time Frame: Every 1-2 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
-
Device: TheraSphere Yttrium-90 microspheres
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 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 |
Inclusion Criteria:
- Clinical diagnosis of hepatocellular carcinoma (tissue diagnosis not required) not amenable to surgical resection, radiofrequency ablation or cryoablation
- Age greater than 18
- Bilirubin less the 3.0 mg/dl
- Albumin greater than 2.2 mg/dl
- Prothrombin time INR less than 1.7 control
- Platelet count greater than 50,000
- Able to give informed consent
- Expected life expectancy of less than 1 year, if untreated
Exclusion Criteria:
- Pregnancy
- Portal vein thrombosis
- Medically uncontrolled ascites
- History of stage III or IV encephalopathy
- Gastrointestinal flow from hepatic artery, as described by Tc-99c MAA study
- Pulmonary shunting of 30Gy (15.m Ci of injected activity), as determined by Tc-99m MAA study
- Significant concurrent medical illness (renal failure, congestive heart failure, severe COPD, etc.)
Contacts and Locations| Contact: Katherine M Gebhardt, PA-C | 714-456-3887 | kgebhard@uci.edu |
| Contact: Tricia Hoang, RN | 714-456-3886 | triciah@uci.edu |
| United States, California | |
| University of California Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Katherine M Gebhardt, PA-C 714-456-3887 kgebhard@uci.edu | |
| Contact: Tricia Hoang, RN 714-456-3886 triciah@uci.edu | |
| Principal Investigator: David K Imagawa, MD, PhD | |
| Principal Investigator: | David K Imagawa, MD, PhD | University of California, Irvine |
More Information
Additional Information:
Publications:
| Responsible Party: | David K. Imagawa, MD, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00906984 History of Changes |
| Other Study ID Numbers: | 2002-2242, CA-60396,, PHS-NIH Natl Cancer Inst |
| Study First Received: | December 27, 2007 |
| Last Updated: | October 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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 May 21, 2013