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

NCT ID: NCT00532740

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2022-03-16

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.

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.

Conditions

Liver Cancer; Metastatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Yttrium Y 90 glass microspheres

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Riad Salem, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18520231 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18349311 (View on PubMed)

Other Identifiers

P30CA060553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NU-1365-002

Identifier Type: -

Identifier Source: secondary_id

NU 1365-002

Identifier Type: -

Identifier Source: org_study_id