A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Confirmed diagnosis of metastatic 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

- FDA approval to receive compassionate use of yttrium Y 90 glass microspheres

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

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

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

- Cumulative delivery of radiotherapy to the lungs over multiple treatments

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute granulocyte count ≥ 1,500/µL

- Platelet count ≥ 25,000/μL

- 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)

- No contraindication to angiography or selective visceral catheterization, including
any of the following:

- 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

- No severe liver dysfunction or pulmonary insufficiency

- No active uncontrolled infection

- No significant underlying medical or psychiatric illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No evidence of any detectable technetium-99 macroaggregated albumin (Tc-99 MAA) flow
to the stomach or duodenum after application of established angiographic techniques
to stop such flow

- No comorbid disease or condition that would preclude safe delivery of yttrium Y 90
glass microspheres and place patient at undue risk

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 4 weeks since prior radiotherapy

- More than 2 weeks since prior surgery

- At least 2 weeks since prior radiosensitizing chemotherapy

- More than 6 weeks since prior carmustine (BCNU) or mitomycin C

- No other concurrent cancer therapy