Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Liver Cancer; Metastatic Cancer	Radiation: Yttrium Y 90 glass microspheres

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	2000 participants
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
Study Start Date :	December 2004
Estimated Primary Completion Date :	April 2018
Estimated Study Completion Date :	April 2019

Groups and Cohorts

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Group/Cohort	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Patient experience and toxicity associated with TheraSphere® treatment [ Time Frame: During & at completion of treatment. ]
   Evaluate patient experience and toxicities associated with TheraSphere® treatment.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with metastatic cancer of the liver who are not surgical resection candidates.

Criteria

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

Study Chair:	Riad Salem, MD	Robert H. Lurie Cancer Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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.

Responsible Party:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00532740 History of Changes
Other Study ID Numbers:	NU 1365-002; P30CA060553 ( U.S. NIH Grant/Contract ); NU-1365-002
First Posted:	September 20, 2007
Last Update Posted:	January 8, 2018
Last Verified:	January 2018

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; Liver Extracts; Hematinics