A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Confirmed diagnosis of 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

- No significant extrahepatic disease representing an imminent life-threatening outcome

- No evidence of potential delivery of > 16.5 mCi (30 Gy absorbed dose) radiation to
the lungs on either of the following:

- First yttrium Y 90 glass microspheres (TheraSphere®) administration

- Cumulative delivery of radiation to the lungs over multiple treatments

PATIENT CHARACTERISTICS:

Inclusion criteria:

- ECOG performance status 0-2

- Absolute granulocyte count ≥ 1,500/μL

- Platelet count > 25,000/μL

- Serum 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)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

Exclusion criteria:

- 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, 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

- Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or
duodenum, after application of established angiographic techniques to stop such flow

- Severe liver dysfunction or pulmonary insufficiency

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior and no other concurrent anticancer therapy