Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

NO_LONGER_AVAILABLE

Conditions studied: Carcinoma, Hepatocellular, Neoplasm Metastasis

In brief

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.

Key facts

Study ID

NCT00701168

Run by

Leo W. Jenkins Cancer Center

Last updated by the study team

2017-08-23

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
• The cancer must be unresectable with limited established treatment options
• ECOG Performance Status Score 0-2
• Age 19 years or older
• Able to comprehend and provide written informed consent

You may not qualify if…

• Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
• Absolute granulocyte count ≤ 1,500/ul
• Platelet count ≤ 75,000/ul
• Serum creatinine > 2.0 mg/dl
• Serum bilirubin ≥ 2.0 mg/dl
• Any of the following contraindications to angiography and selective visceral catheterization:
• History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
• Bleeding, diathesis, not correctable by usual forms of therapy
• Severe peripheral vascular disease that would preclude catheterization
• Substantial venous shunt away from the liver
• Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
• Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
• Significant extrahepatic disease representing an imminent life- threatening situation outcome
• Severe liver dysfunction or pulmonary insufficiency
• Active uncontrolled infection
• Significant underlying medical or psychiatric illness
• Pregnant women may not participate

Where it is running

• Leo W Jenkins Cancer Center at East Carolina University School of Medicine — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.