Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
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Purpose
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery.
PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
| Condition | Intervention |
|---|---|
|
Liver Cancer |
Radiation: yttrium Y 90 glass microspheres |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma |
- Proportion of patients completing scheduled treatment plan [ Time Frame: At point that patient discontinues treatment for whatever reason. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
-
Radiation: yttrium Y 90 glass microspheres
OBJECTIVES:
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with unresectable cancer primarily in the liver with the liver being the only site of disease or the dominant site of disease
DISEASE CHARACTERISTICS:
Confirmed diagnosis of intrahepatic carcinoma
- Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP
- Unresectable disease
- No portal hypertension with portal venous shunt away from the liver
- No significant extrahepatic disease representing an imminent life-threatening outcome
No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following:
- First yttrium Y 90 glass microspheres (TheraSphere®) administration
- Cumulative delivery of radiation to the lungs over multiple treatments
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/μL
- Platelet count > 25,000/μL
- Serum creatinine < 2.0 mg/dL (unless using non-iodinated contrast or on dialysis)
- Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Exclusion criteria:
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, that cannot be controlled using basic angiographic techniques
- Bleeding diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization
- Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior and no other concurrent anticancer therapy
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
| Chicago, Illinois, United States, 60611-3013 | |
| Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancertrials@northwestern.edu | |
| Study Chair: | Riad Salem, MD | Robert H. Lurie Cancer Center |
More Information
Publications:
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00530010 History of Changes |
| Other Study ID Numbers: | NU 1365-001, P30CA060553, NU-1365-001 |
| Study First Received: | September 13, 2007 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 17, 2013