Radiolabeled Glass Beads in Treating Patients With Metastatic 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 metastatic liver cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer Metastatic Cancer |
Radiation: Yttrium Y 90 glass microspheres |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver |
- Patient experience and toxicity associated with TheraSphere® treatment [ Time Frame: During & at completion of treatment. ] [ Designated as safety issue: Yes ]Evaluate patient experience and toxicities associated with TheraSphere® treatment.
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
All Patients
Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care.
|
Radiation: Yttrium Y 90 glass microspheres
Between 0.2 to 0.5 Curies (200-500-mCi), either single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart per treating physician's discretion.
|
Detailed Description:
OBJECTIVES:
- Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients who are not candidates for surgical resection of metastatic intrahepatic carcinoma.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres 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 therapy 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study therapy, 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 metastatic cancer of the liver who are not surgical resection candidates.
DISEASE CHARACTERISTICS:
Confirmed diagnosis of metastatic 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
- FDA approval to receive compassionate use of yttrium Y 90 glass microspheres
- No significant extrahepatic disease representing an imminent life-threatening outcome
No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either of the following:
- First administration of yttrium Y 90 glass microspheres (TheraSphere ®)
- Cumulative delivery of radiotherapy to the lungs over multiple treatments
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute granulocyte count ≥ 1,500/µL
- Platelet count ≥ 25,000/μL
- 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)
No contraindication to angiography or selective visceral catheterization, including any of the following:
- 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
- No severe liver dysfunction or pulmonary insufficiency
- No active uncontrolled infection
- No significant underlying medical or psychiatric illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of any detectable technetium-99 macroaggregated albumin (Tc-99 MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop such flow
- No comorbid disease or condition that would preclude safe delivery of yttrium Y 90 glass microspheres and place patient at undue risk
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- More than 2 weeks since prior surgery
- At least 2 weeks since prior radiosensitizing chemotherapy
- More than 6 weeks since prior carmustine (BCNU) or mitomycin C
- No other concurrent cancer 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: | NCT00532740 History of Changes |
| Other Study ID Numbers: | NU 1365-002, P30CA060553, NU-1365-002 |
| Study First Received: | September 18, 2007 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
liver metastases advanced adult primary liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013