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

NCT00532740 | Completed DMC

• 3 other identifiers: NU 1365-002P30CA060553NU-1365-002
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Metastatic Cancer

Keywords

liver metastases; advanced adult primary liver cancer

Study Arms (1)

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

Interventions

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.

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Related Publications (2)

• 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.

  PMID: 18520231 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.

  PMID: 18349311 RESULT

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riad Salem, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 20, 2007
• Study Start: December 1, 2004
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

US (1)