Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU-1365-002 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium Y 90 glass microspheres | Radiation | 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. |
DISEASE CHARACTERISTICS:
Confirmed diagnosis of metastatic intrahepatic carcinoma
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:
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:
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:
Not provided
Not provided
Not provided
Patients with metastatic cancer of the liver who are not surgical resection candidates.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Riad Salem, MD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18520231 | Result | Rhee TK, Lewandowski RJ, Liu DM, Mulcahy MF, Takahashi G, Hansen PD, Benson AB 3rd, Kennedy AS, Omary RA, Salem R. 90Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Ann Surg. 2008 Jun;247(6):1029-35. doi: 10.1097/SLA.0b013e3181728a45. | |
| 18349311 | Result | Sato KT, Lewandowski RJ, Mulcahy MF, Atassi B, Ryu RK, Gates VL, Nemcek AA Jr, Barakat O, Benson A 3rd, Mandal R, Talamonti M, Wong CY, Miller FH, Newman SB, Shaw JM, Thurston KG, Omary RA, Salem R. Unresectable chemorefractory liver metastases: radioembolization with 90Y microspheres--safety, efficacy, and survival. Radiology. 2008 May;247(2):507-15. doi: 10.1148/radiol.2472062029. Epub 2008 Mar 18. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |