Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

NCT00039078 | Withdrawn Phase 2 FDA Device

• 5 other identifiers: PCI-IRB-0611014CDR0000069336PCI-IRB-000656PCI-IRB-000871NCI-V02-1701
• Study Type: interventional
• Target: N/A
• 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 the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (3)

• Response to treatment

• Survival time from treatment

• Adverse experiences

Interventions

yttrium Y 90 glass microspheres RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Confirmed diagnosis of hepatocellular carcinoma (HCC) * Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level * No significant extrahepatic disease that may represent an imminent life-threatening outcome * No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * No hepatic dysfunction * Bilirubin ≤ 2.0 mg/dL * No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization * No pulmonary insufficiency * No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow * No contraindications to angiography * No contraindications to selective visceral catheterization * No other condition or cormorbidity that would preclude study treatment * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 30 days after study PRIOR CONCURRENT THERAPY: * At least 1 month since prior chemotherapy, radiotherapy, or surgery * No other concurrent investigational agents or anticancer therapy for HCC

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

Sponsors & Collaborators

• Allan Tsung: lead

Study Sites (1)

UPMC Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• Goin JE, Salem R, Carr BI, Dancey JE, Soulen MC, Geschwind JF, Goin K, Van Buskirk M, Thurston K. Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: a risk-stratification analysis. J Vasc Interv Radiol. 2005 Feb;16(2 Pt 1):195-203. doi: 10.1097/01.RVI.0000142602.79459.90.

  PMID: 15713920 BACKGROUND

• Geschwind JF, Salem R, Carr BI, Soulen MC, Thurston KG, Goin KA, Van Buskirk M, Roberts CA, Goin JE. Yttrium-90 microspheres for the treatment of hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S194-205. doi: 10.1053/j.gastro.2004.09.034.

  PMID: 15508085 BACKGROUND

• Salem R, Thurston KG, Carr BI, Goin JE, Geschwind JF. Yttrium-90 microspheres: radiation therapy for unresectable liver cancer. J Vasc Interv Radiol. 2002 Sep;13(9 Pt 2):S223-9. doi: 10.1016/s1051-0443(07)61790-4.

  PMID: 12354840 BACKGROUND

• Carr BI. Hepatic arterial 90Yttrium glass microspheres (Therasphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients. Liver Transpl. 2004 Feb;10(2 Suppl 1):S107-10. doi: 10.1002/lt.20036.

  PMID: 14762849 RESULT

• Carr BI, Sheetz M, Brown M, et al.: Hepatic arterial 90yttrium-labeled glass microspheres (Therasphere) as treatment for unresectable HCC in forty three patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-553, 2002.

  RESULT

• Carr BI, Brown M, France M, et al.: 90 yttrium labeled glass microspheres in the treatment of hepatocellular carcinoma: initial US experience. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2346, 2001.

  RESULT

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• T. Clark Gamblin, MD

  UPMC Cancer Center at UPMC Presbyterian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Primary Completion: August 1, 2000
• Study Completion: August 1, 2000
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

US (1)