Clinical trial NCT00039078: Radiolabeled Glass Beads (TheraSphere®) in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Official title: The Use of TheraSphere® for the Treatment of Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Liver Cancer
Keywords: localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed description: OBJECTIVES:

* Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma.
* Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres.
* Determine the toxic effects and adverse experiences associated with this therapy in these patients.
* Determine the survival time of patients treated with this therapy.
* Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy.
* Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy.
* Assess the quality of life of patients treated with this therapy.

OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time.

Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.

Eligibility criteria: 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

Primary outcomes:
measure: Response to treatment
measure: Survival time from treatment
measure: Adverse experiences
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Liver Cancer Center
state: Pennsylvania
Study officials:
affiliation: UPMC Cancer Center at UPMC Presbyterian
name: T. Clark Gamblin, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.