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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Leo W. Jenkins Cancer Center

Conditions:

Carcinoma, Hepatocellular

Neoplasm Metastasis

Eligibility:

All Genders

19+ years

Brief Summary

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 tre...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00701168

Last Update

August 23 2017

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